Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- GCJLaparoscope, General & Plastic Surgery2Product Code
- K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K250927KARL STORZ Cholangiography Set2Cleared 510(K)
- K242606Nuvis® Wireless HD Camera System (Nuvis-2K)2Cleared 510(K)
- K252442Kii Structural Balloon Access System2Cleared 510(K)
- K2526973D Laparoscope2Cleared 510(K)
- K252640VereSee Optical Veres Needle and Endoscopic Camera2Cleared 510(K)
- K251994Arthrex Synergy Vision Imaging System2Cleared 510(K)
- K243968Revolve Surgical System2Cleared 510(K)
- K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)2Cleared 510(K)
- K251743SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System2Cleared 510(K)
- K250130Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)2Cleared 510(K)
- K250124Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)2Cleared 510(K)
- K252010SPY Laparoscope2Cleared 510(K)
- K250820Disposable Trocars2Cleared 510(K)
- K2514908 mm Assist Cannula; 12 mm Assist Cannula2Cleared 510(K)
- K243399Boehringer Laboratories Liver Retractor2Cleared 510(K)
- K251209Medical Monitor (32HS710S)2Cleared 510(K)
- K250728Arthrex Synergy Vision Endoscopic Imaging System2Cleared 510(K)
- K243867LAGIS Suction Irrigation System2Cleared 510(K)
- K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System2Cleared 510(K)
- K243439Medical Monitor (27HS714S)2Cleared 510(K)
- K243008Arthrex NanoScope System2Cleared 510(K)
- K243307LCD Monitor (MDEC-2523)2Cleared 510(K)
- K242927Suction Irrigation Tubing Set2Cleared 510(K)
- K240831MultiCut Solo2Cleared 510(K)
- K240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)2Cleared 510(K)
- K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)2Cleared 510(K)
- K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)2Cleared 510(K)
- K241052Bladeless Trocar; Bladed Trocar; Hasson Trocar2Cleared 510(K)
- K241913da Vinci Handheld Camera2Cleared 510(K)
- K241401Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K241402Medical Monitor (32HR734S)2Cleared 510(K)
- K241530Stellar Imaging System2Cleared 510(K)
- K241360Universal Seal (5-12 mm)2Cleared 510(K)
- K241361Arthrex Synergy Vision Endoscopic Imaging System2Cleared 510(K)
- K241502P-SCOPE2Cleared 510(K)
- K241739Endoscopic Applicator, 41 cm2Cleared 510(K)
- K241111AMT Suture Passer2Cleared 510(K)
- K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)2Cleared 510(K)
- K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)2Cleared 510(K)
- K240196Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)2Cleared 510(K)
- K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)2Cleared 510(K)
- K233386Monik™ - Disposable Endoscopic Trocar2Cleared 510(K)
- K240205Ez Catch Auto; Ez Catch YR; Ez Catch TR2Cleared 510(K)
- K233263Disposable Trocars2Cleared 510(K)
- K240635ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm2Cleared 510(K)
- K2401741688 4K Camera System with Advanced Imaging Modality2Cleared 510(K)
- K233451Arthrex Synergy Vision Endoscopic Imaging System2Cleared 510(K)
- K222783MD Mattress Suture Placement Device2Cleared 510(K)
- K2333271788 4K Camera System with Advanced Imaging Modality2Cleared 510(K)
- K232519ENDOCOLLECT Specimen Retrieval Bag2Cleared 510(K)
- K231066CuratOR EX3242-FD2Cleared 510(K)
- K232866Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)2Cleared 510(K)
- K232880Inzii Ripstop Redeployable Retrieval System2Cleared 510(K)
- K232042NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);2Cleared 510(K)
- K231725Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)2Cleared 510(K)
- K232701Guardenia (GAR-1)2Cleared 510(K)
- K231622REGER Nebulizer Irrigation Cannula2Cleared 510(K)
- K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K231400Bladeless Trocar – Artemis Lap Cannula2Cleared 510(K)
- K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)2Cleared 510(K)
- K231358Universal Seal (5-12 mm)2Cleared 510(K)
- K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-2Cleared 510(K)
- K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K231042Disposable Laparoscopic Trocar2Cleared 510(K)
- K223718HandX™ Self-Righting Needle Holder2Cleared 510(K)
- K223562Xpan Universal Trocar System2Cleared 510(K)
- K230491HandX™ Monopolar Scissors2Cleared 510(K)
- K230058Bladeless Trocar – Artemis Lap Cannula2Cleared 510(K)
- K2306051788 4K Camera System with Advanced Imaging Modality2Cleared 510(K)
- K223923HOPKINS Telescopes2Cleared 510(K)
- K223593Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar2Cleared 510(K)
- K222828Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A2Cleared 510(K)
- K2231168X-10-6XXX Camera Head2Cleared 510(K)
- K223759Arthrex SynergyID Endoscopic Imaging System2Cleared 510(K)
- K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)2Cleared 510(K)
- K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source2Cleared 510(K)
- K221861FloNavi Endoscopic Fluorescence Imaging System2Cleared 510(K)
- K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH2Cleared 510(K)
- K213597MultiCut Solo2Cleared 510(K)
- K221252Scivita 4KINSIGHT ICG Imaging System2Cleared 510(K)
- K222011HandX Instrument - Monopolar Spatula2Cleared 510(K)
- K221004HOPKINS Telescopes2Cleared 510(K)
- K222575HurriChem Device Kit2Cleared 510(K)
- K212736Canady Flex RoboWrist2Cleared 510(K)
- K222504H12Cleared 510(K)
- K221740SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)2Cleared 510(K)
- K222890RADIANCE ULTRA 32 4K ZEROWIRE DUO2Cleared 510(K)
- K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control2Cleared 510(K)
- K221533Plasma Shield2Cleared 510(K)
- K221365LapBox Tissue Containment Removal System2Cleared 510(K)
- K2221301688 4K Camera System with Advanced Imaging Modality2Cleared 510(K)
- K213818VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula2Cleared 510(K)
- K211148CORE-Trocar2Cleared 510(K)
- K221217SPY Laparoscope2Cleared 510(K)
- K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable2Cleared 510(K)
- K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)2Cleared 510(K)
- K220872Saberscope5 Laparoscope2Cleared 510(K)
- K211043Alexis Contained Extraction System2Cleared 510(K)
- K213860ArthroFree Wireless Surgical Camera System2Cleared 510(K)
- K2200694K UHD LCD Monitor OEV321UH2Cleared 510(K)
- K220108SDC4K Information Management System with Device and Voice Control Package2Cleared 510(K)
- K212055Connected OR Hub with Device and Voice Control2Cleared 510(K)
- K212500ArtiSential Trocar2Cleared 510(K)
- K212950FUJIFILM Video Laparoscope EL-R740M302Cleared 510(K)
- K211577SoftFix Balloon Trocar2Cleared 510(K)
- K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)2Cleared 510(K)
- K211234RedEx2Cleared 510(K)
- K212214HandX2Cleared 510(K)
- K210248Lab Bag with Fabric Pouch2Cleared 510(K)
- K202582Arthrex SynergyID Endoscopic Imaging System2Cleared 510(K)
- K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-02Cleared 510(K)
- K202551Cor-Knot Micro2Cleared 510(K)
- K211250VisionPort System2Cleared 510(K)
- K210495Port Access System2Cleared 510(K)
- K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes2Cleared 510(K)
- K210584SDC3 HD Information Management System with Wireless Device Control Capability2Cleared 510(K)
- K2032554K UHD Laparoscope2Cleared 510(K)
- K202303CORE E3 Suction/irrigator2Cleared 510(K)
- K203603Monopolar Hook2Cleared 510(K)
- K201526TIPCAM1 Rubina Video Endoscope System2Cleared 510(K)
- K202931Disposable Trocar2Cleared 510(K)
- K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)2Cleared 510(K)
- K201134Arthrex NanoScope System2Cleared 510(K)
- K201805VersaOne Reusable Positioning Trocar System2Cleared 510(K)
- K202130FUJIFILM Video Laparoscope2Cleared 510(K)
- K201641Disposable Laparoscope Trocar2Cleared 510(K)
- K192499Cyber Blade2Cleared 510(K)
- K201434Connected OR Hub with Voice Control, Connected OR Hub with Device Control2Cleared 510(K)
- K201198S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable2Cleared 510(K)
- K201243Disposable Specimen Retrieval Bag2Cleared 510(K)
- K193272GTK Trocars2Cleared 510(K)
- K201593Looking Glass 4K Integrated Visualization System2Cleared 510(K)
- K201151O-Mec 690 Series Laparoscopes2Cleared 510(K)
- K200902ClickClean2Cleared 510(K)
- K191866GelPOINT Mini Advanced Access Platform2Cleared 510(K)
- K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)2Cleared 510(K)
- K193161Pristine Scope2Cleared 510(K)
- K1919307 mm Extended Length Endoscope2Cleared 510(K)
- K200517Standard Trocar2Cleared 510(K)
- K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3D2Cleared 510(K)
- K192300EnlightenVue Microendoscopy System2Cleared 510(K)
- K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality2Cleared 510(K)
- K192918Video Laparoscope, Video Processor, Light Source2Cleared 510(K)
- K200228ClearCam System2Cleared 510(K)
- K193315Xenocor Articulating Xenoscope Laparoscope2Cleared 510(K)
- K191678IP Converter2Cleared 510(K)
- K193137EASYGRIP FLO-41 Precision MIS Delivery System2Cleared 510(K)
- K192643Dannik Laparoscopic Suction Irrigation System2Cleared 510(K)
- K192891Laparoscope Lens Shield Device (LENS)2Cleared 510(K)
- K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar2Cleared 510(K)
- K1836753D Visualization System2Cleared 510(K)
- K192172Connected OR Hub with Device and Voice Control2Cleared 510(K)
- K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head2Cleared 510(K)
- K191295Percutaneous Introducer Needle2Cleared 510(K)
- K190645Arthrex NanoScope System2Cleared 510(K)
- K191043da Vinci Handheld Camera2Cleared 510(K)
- K190831E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor2Cleared 510(K)
- K190592YelloPort Elite Port Access System2Cleared 510(K)
- K190788Disposable Standard Clamp2Cleared 510(K)
- K181173ELMED Laparoscopic Instruments and Accessories2Cleared 510(K)
- K183600Anchor Bag-Alone Tissue Retrieval System by ConMed2Cleared 510(K)
- K183264Flex-THOR scope2Cleared 510(K)
- K182434LaparoGuard2Cleared 510(K)
- K182606PINPOINT Endoscopic Fluorescence Imaging System2Cleared 510(K)
- K173917neoClose PDS2Cleared 510(K)
- K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM2Cleared 510(K)
- K181258ConnectedOR Hub with Device and Voice Control2Cleared 510(K)
- K181608Disposable Standard Clamp2Cleared 510(K)
- K182080Scope Antifogging System2Cleared 510(K)
- K173822Anchor Tissue Retrieval System by CONMED2Cleared 510(K)
- K182024Dissecting Balloon System2Cleared 510(K)
- K181791SIMPLYSTRONG, SIMPLYEZEE2Cleared 510(K)
- K181395Universal Cannula Seal (5-12 mm)2Cleared 510(K)
- K180977KARL STORZ New Generation Trocars2Cleared 510(K)
- K180836Genistrong2Cleared 510(K)
- K180208Disposable Endoscopic Trocar2Cleared 510(K)
- K180114AEON Retrieval Bag2Cleared 510(K)
- K173919HX Device2Cleared 510(K)
- K180579Ezee Retrieval2Cleared 510(K)
- K171939ALVUE Balloon Dilation System2Cleared 510(K)
- K170683Aesculap Video Assisted Thoracic Surgery (VATS) INstruments2Cleared 510(K)
- K173272Ergonomic Handle2Cleared 510(K)
- K172789Specimen Retrieval Bag2Cleared 510(K)
- K172578Equipment Pouch2Cleared 510(K)
- K172618SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 12Cleared 510(K)
- K172794Suction Irrigation Set2Cleared 510(K)
- K172038Trocar2Cleared 510(K)
- K172940ANCHOR Tissue Retrieval System2Cleared 510(K)
- K172672Endoscopic Applicator, 41 cm2Cleared 510(K)
- K171726LapBag2Cleared 510(K)
- K171741Laport2Cleared 510(K)
- K171475DeRoyal Laprador Specimen Retrieval System2Cleared 510(K)
- K170379Disposable Standard Clamp2Cleared 510(K)
- K171344Xenocor Xenoscope Laparoscopic System2Cleared 510(K)
- K17089927HJ713S2Cleared 510(K)
- K170598ZeroWire Mobile2Cleared 510(K)
- K170030NOVATECH TALCAIR2Cleared 510(K)
- K162836FUJIFILM Surgical System2Cleared 510(K)
- K170084InterLock Trocar2Cleared 510(K)
- K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar2Cleared 510(K)
- K170103Laparoscope Lens Shield Device (LENS)2Cleared 510(K)
- K162197EndoClot2Cleared 510(K)
- K162387U-IGNITE Bladeless Trocar2Cleared 510(K)
- K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm2Cleared 510(K)
- K160801Well Lead Extraction Bag2Cleared 510(K)
- K153773Disposal Lens Cleaning Sheath2Cleared 510(K)
- K161720Standard Clamp2Cleared 510(K)
- K162445LiVac Retractor System2Cleared 510(K)
- K162584VersaOne Bladeless Trocar2Cleared 510(K)
- K162059EZEE RETRIEVAL2Cleared 510(K)
- K161838Xenocor Xenoscope Laparoscopic System2Cleared 510(K)
- K161792PINPOINT Endoscopic Fluorescence Imaging System2Cleared 510(K)
- K153542Pelican Sling Retractor2Cleared 510(K)
- K162077Laparoscopic Spray Applicator with Spinning Luers2Cleared 510(K)
- K161421Single Use Surgical Suction Irrigator2Cleared 510(K)
- K161122Sony IP Converter NU-IP40S2Cleared 510(K)
- K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application2Cleared 510(K)
- K161228Radiance Ultra Series ZeroWire Embedded2Cleared 510(K)
- K160393AdTec2Cleared 510(K)
- K150956PINPOINT Endoscopic Fluorescence Imaging System2Cleared 510(K)
- K160332Stryker SDC3 HD Information Management System with Wireless Device Control Capability2Cleared 510(K)
- K161017True HD 3MOS Camera System2Cleared 510(K)
- K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)2Cleared 510(K)
- K160172Laparoscope Lens Shield Device2Cleared 510(K)
- K151832NOVATECH TALCAIR2Cleared 510(K)
- K160230VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm2Cleared 510(K)
- K153218Arthrex Synergy UHD4 System2Cleared 510(K)
- K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments2Cleared 510(K)
- K152400General & Plastic Surgery Instruments2Cleared 510(K)
- K152149VersaOne Bladed Trocar 5mm2Cleared 510(K)
- K1525138X-10-XXXX Camera System2Cleared 510(K)
- K153126da Vinci Xi Hasson Cone2Cleared 510(K)
- K152848AUTOLAP SYSTEM2Cleared 510(K)
- K151609ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G22Cleared 510(K)
- K151489Retrieval bag system2Cleared 510(K)
- K152663Bladeless Optical Obturators2Cleared 510(K)
- K152565Auto Suture Locking Trocar2Cleared 510(K)
- K143640KSEA CMOS Camera System (C-cam)2Cleared 510(K)
- K151990Tissue Removal System2Cleared 510(K)
- K151822ab medica irrigation/suction gravity system2Cleared 510(K)
- K151117Laparoscope Lens Shield Device2Cleared 510(K)
- K141594Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar2Cleared 510(K)
- K150377Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor2Cleared 510(K)
- K151548VersaOne Bladed Trocar, VersaOne Bladeless Trocar2Cleared 510(K)
- K150781Tissue Removal Pouch2Cleared 510(K)
- K151356Spacemaker Pro Access and Dissector System2Cleared 510(K)
- K150569LaparoVue2Cleared 510(K)
- K150549Reactor(TM) Trocar and Sleeve2Cleared 510(K)
- K141902LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER2Cleared 510(K)
- K150633ULTRA Telescopes2Cleared 510(K)
- K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator2Cleared 510(K)
- K150253Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm2Cleared 510(K)
- K141715GLOVE PORT2Cleared 510(K)
- K142464Entriport2Cleared 510(K)
- K150127Laparoscopic Handles with peek Insulation2Cleared 510(K)
- K143299Percuvance(R) Percutaneous Surgical System2Cleared 510(K)
- K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 252Cleared 510(K)
- K140593ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE2Cleared 510(K)
- K142547Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm2Cleared 510(K)
- K143221Schoelly Laparoscope2Cleared 510(K)
- K143091Surgisleeve Wound Protector2Cleared 510(K)
- K141593UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH2Cleared 510(K)
- K142903neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US2Cleared 510(K)
- K142603Stryker Precision HD Camera System2Cleared 510(K)
- K141272FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR2Cleared 510(K)
- K141592UNIMICRO SUCTION IRRIATION TUBING SET2Cleared 510(K)
- K140101ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS2Cleared 510(K)
- K132375GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG2Cleared 510(K)
- K140662FLEX ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K141323VTI SUCTION IRRIGATION SYSTEM2Cleared 510(K)
- K133272VERSACUT + TISSUE MORCELLATOR2Cleared 510(K)
- K133203SINGLE-SITE PORT2Cleared 510(K)
- K133345REVEEL ENDOSCOPIC RETRACTOR2Cleared 510(K)
- K1338458MM TROCAR KIT2Cleared 510(K)
- K133375BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR2Cleared 510(K)
- K132785STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY2Cleared 510(K)
- K123728RETRIEVAL BAG2Cleared 510(K)
- K131375AUTOLAP SYSTEM2Cleared 510(K)
- K132169SURGIQUEST AIRSEAL IFS2Cleared 510(K)
- K130826PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER2Cleared 510(K)
- K131688NEOCLOSE HASSON, NEOCLOSE UNIVERSAL2Cleared 510(K)
- K131115ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE2Cleared 510(K)
- K123280NEOCLOSE HASSON, NEOCLOSE UNIVERSAL2Cleared 510(K)
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- K031720MODIFICATION TO HERMES O.R. CONTROL CENTER2Cleared 510(K)
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- K020428ENDOPATH DILATING TIP TROCAR, MODEL #512XD2Cleared 510(K)
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- K013952INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM2Cleared 510(K)
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- K013617LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS2Cleared 510(K)
- K013576PERICSCOPE, MODEL # PERISC12Cleared 510(K)
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- K012884DILATING TIP OBTURATOR2Cleared 510(K)
- K0142507MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-11142Cleared 510(K)
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- K013695MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-102Cleared 510(K)
- K013090SOPRO 67D OPERATING ROOM CAMERA2Cleared 510(K)
- K012968APPLIED ACCESS SEAL2Cleared 510(K)
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- K012527KSEA SIALOENDOSCOPES AND ACCESSORIES2Cleared 510(K)
- K003431ZEUS ROBOTIC SURGICAL SYSTEM2Cleared 510(K)
- K012150PATTON ENDO-BAG2Cleared 510(K)
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- K011841KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR2Cleared 510(K)
- K012539VERASTEP2Cleared 510(K)
- K010754NURSE'S ASSISTANT O.R. CONTROL SYSTEM2Cleared 510(K)
- K011538ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM2Cleared 510(K)
- K011501ENDOPOUCH RETRIEVER2Cleared 510(K)
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- K011189VIADUCT MICROENDOSCOPE AND ACCESSORIES2Cleared 510(K)
- K011257ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)2Cleared 510(K)
- K011997MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX2Cleared 510(K)
- K011359MODIFICATION TO KSEA ENDOTIP SYSTEM2Cleared 510(K)
- K010870LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD1132Cleared 510(K)
- K011183OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE2Cleared 510(K)
- K003871LAPAROSCOPIC HAND PORT2Cleared 510(K)
- K010620ENDOSCOPIC STAPLE REMOVAL INSTRUMENT2Cleared 510(K)
- K010519MAGNUM FLOW IRRIGATION SYSTEM2Cleared 510(K)
- K010346KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR2Cleared 510(K)
- K011016LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT2Cleared 510(K)
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- K010569KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP2Cleared 510(K)
- K010220XTRACTOR, MODEL M1432Cleared 510(K)
- K003803GENERAL SURGICAL LAPAROSCOPES2Cleared 510(K)
- K010007ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP2Cleared 510(K)
- K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 55520052Cleared 510(K)
- K003217HERMES PORT EXPANDER2Cleared 510(K)
- K0029243D ENDOSCOPE2Cleared 510(K)
- K002431ELRAN 01 SYSTEM2Cleared 510(K)
- K002542REUSABLE CANNULA2Cleared 510(K)
- K002013OMNIPORT2Cleared 510(K)
- K001666MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM2Cleared 510(K)
- K992182CA GUARD, LTD. PSP (PORT SITE PROTECTOR)2Cleared 510(K)
- K0015943.5 MM LAPAROSCOPE (LG100, LG103)2Cleared 510(K)
- K001597CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX2Cleared 510(K)
- K000769KSEA MANHES PNEUMOTROCAR2Cleared 510(K)
- K001264EAGLE ENDO SPECIMEN RETRIEVAL BAG2Cleared 510(K)
- K000669MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY2Cleared 510(K)
- K001169OPTIVU HDVD SYSTEM2Cleared 510(K)
- K000493STRYKER IRRIGATION TUBE SET2Cleared 510(K)
- K000663KRONNER LOW PROFILE SCOPE HOLDER2Cleared 510(K)
- K000545SENTRY EXPANDING INTRODUCER SHEATH (EIS)2Cleared 510(K)
- K000337MTP DISPOSABLE TROCAR VALVES2Cleared 510(K)
- K000423S52D DIGITAL VIDEO LAPAROSCOPE2Cleared 510(K)
- K000422S57D DIGITAL OPERATING ROOM CAMERA2Cleared 510(K)
- K000424S51D DIGITAL ENDOSCOPY CAMERA2Cleared 510(K)
- K000202CORTEK LAPAROSCOPES2Cleared 510(K)
- K994256SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-8232Cleared 510(K)
- K994066MTP DISPOSABLE TROCARS2Cleared 510(K)
- K993688AED LAPAROSCOPE2Cleared 510(K)
- K992852SUTURE CLINCH2Cleared 510(K)
- K993045BARIATRIC LAPAROSCOPE, MODEL 3672Cleared 510(K)
- K992612ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW2322Cleared 510(K)
- K992250CORE AUDIBLE TROCAR II2Cleared 510(K)
- K992437SCHOELLY RIGID ENDOSCOPES2Cleared 510(K)
- K992190CORE POUCH2Cleared 510(K)
- K990785TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K992541LAPAROCAM2Cleared 510(K)
- K992324FUNNEL TROCAR2Cleared 510(K)
- K990724CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES2Cleared 510(K)
- K991718OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D2Cleared 510(K)
- K992353BLUNT TIP TROCAR PORT2Cleared 510(K)
- K992288AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE2Cleared 510(K)
- K991416ENDOSCOPIC CAMERA2Cleared 510(K)
- K991382SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-1012Cleared 510(K)
- K991377OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER2Cleared 510(K)
- K991303VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE2Cleared 510(K)
- K990237TROCAR SYSTEM ACCORDING TO HASSON2Cleared 510(K)
- K991928MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS2Cleared 510(K)
- K991444HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).2Cleared 510(K)
- K991228DCI ENDOSCOPE2Cleared 510(K)
- K991171DCI ENDOSCOPE2Cleared 510(K)
- K991734MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER2Cleared 510(K)
- K990912MTP EXTRACTION BAG2Cleared 510(K)
- K984600METRA PS PROCEDURE KIT2Cleared 510(K)
- K991703STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM2Cleared 510(K)
- K991635MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER2Cleared 510(K)
- K990663INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-1502Cleared 510(K)
- K990894ETB TROCAR SYSTEM2Cleared 510(K)
- K990731EASTGATE PERSONAL MONITOR2Cleared 510(K)
- K990635VISTA STEREOSCOPE SYSTEM2Cleared 510(K)
- K990493INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE2Cleared 510(K)
- K990414SMITH & NEPHEW HANDPORT SYSTEM2Cleared 510(K)
- K990188INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-12Cleared 510(K)
- K990028ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE2Cleared 510(K)
- K984355POINT SETTER2Cleared 510(K)
- K990691HERMES OPERATING ROOM CONTROL CENTER2Cleared 510(K)
- K984434MEDIVISION LAPAROSCOPE2Cleared 510(K)
- K990379MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES2Cleared 510(K)
- K983527MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE2Cleared 510(K)
- K9835663-CHIP VIDEO CAMERA2Cleared 510(K)
- K983567IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEM2Cleared 510(K)
- K983623MODULAP2Cleared 510(K)
- K983363DCI ENDOSCOPE2Cleared 510(K)
- K983561FUJINON EVL-F VIDEO LAPROSCOPE2Cleared 510(K)
- K983293AUTO SUTURE LAPAROSCOPES DEVICE2Cleared 510(K)
- K983279ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE2Cleared 510(K)
- K983538MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY2Cleared 510(K)
- K980129INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS)2Cleared 510(K)
- K982013MGB LAPALUX TELESCOPE2Cleared 510(K)
- K982417INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP2Cleared 510(K)
- K982623AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM2Cleared 510(K)
- K981940MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES2Cleared 510(K)
- K982073ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM2Cleared 510(K)
- K982445MODULAP2Cleared 510(K)
- K981999ALBATECH PERSONAL MONITOR2Cleared 510(K)
- K973943INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER2Cleared 510(K)
- K982287ASLAN SENSOR MODULAR INSTRUMENT2Cleared 510(K)
- K981928GALILEO DISPOSABLE ENDOSCOPES2Cleared 510(K)
- K981941MULTAPORT CANNULA REDUCER AND ACCESSORIES2Cleared 510(K)
- K973430KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM2Cleared 510(K)
- K981531SUTURE PLACEMENT DEVICE AND ACCESSORIES2Cleared 510(K)
- K980787HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR2Cleared 510(K)
- K981598HERNIA MESH STABILIZER2Cleared 510(K)
- K981700VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM2Cleared 510(K)
- K974771STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL2Cleared 510(K)
- K980604SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES2Cleared 510(K)
- K980623N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE2Cleared 510(K)
- K980350VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-1502Cleared 510(K)
- K980279SONY DXC-LS1 COLOR VIDEO CAMERA2Cleared 510(K)
- K974382ACKERMANN SURGICAL INSTRUMENTS2Cleared 510(K)
- K980599NTECH ARTHROSCOPE2Cleared 510(K)
- K980079COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES2Cleared 510(K)
- K973698SCION BALLOON ELEVATOR2Cleared 510(K)
- K980023ENDOPATH AND PROXIMATE LINEAR CUTTERS2Cleared 510(K)
- K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET2Cleared 510(K)
- K980022ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)2Cleared 510(K)
- K980050MENTOR SKIN PROTECTION PAD2Cleared 510(K)
- K973909KSEA ENDOTIP SYSTEM2Cleared 510(K)
- K973700HERMES OPERATING ROOM CONTROL CENTER2Cleared 510(K)
- K974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.2Cleared 510(K)
- K974391KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM2Cleared 510(K)
- K973814TRUMP-IT II AND MAGNUM 2502Cleared 510(K)
- K972298ETB TELESCOPE W/WORKING CHANNEL FOR SEPS2Cleared 510(K)
- K974139LQUET CANNULA/TROCAR SYSTEM2Cleared 510(K)
- K974767SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES2Cleared 510(K)
- K973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK2Cleared 510(K)
- K974592INTERCEPTRE LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K973543KRONNER LOW PROFILE SCOPE HOLDER2Cleared 510(K)
- K970888IOTEC TROCAR AND FLEXIBLE CANNULA2Cleared 510(K)
- K974366KSEA PLASTIC TROCARS2Cleared 510(K)
- K973794S-57 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K973795S-52 ELECTRONIC VIDEO LAPAROSCOPE2Cleared 510(K)
- K973796S-41 &41S VIDEO IMAGING SYSTEM2Cleared 510(K)
- K972699AESOP 3000 SYSTEM AND ACCESSORIES2Cleared 510(K)
- K972280GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES2Cleared 510(K)
- K973436VISTA HEAD MOUNTED DISPLAY2Cleared 510(K)
- K973415CURVILINEAR SUTURE PLACEMENT SYSTEM2Cleared 510(K)
- K973249ENDOASSIST2Cleared 510(K)
- K973359PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM2Cleared 510(K)
- K973232OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT2Cleared 510(K)
- K973139ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR2Cleared 510(K)
- K973068KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING2Cleared 510(K)
- K972927ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR2Cleared 510(K)
- K972984LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE2Cleared 510(K)
- K972471DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES2Cleared 510(K)
- K972685ORIGIN LIGATOR DEVICE2Cleared 510(K)
- K972578ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE2Cleared 510(K)
- K970937MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)2Cleared 510(K)
- K971150MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE2Cleared 510(K)
- K972958LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS2Cleared 510(K)
- K972679ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)2Cleared 510(K)
- K972178UNISURGE INTERFACE P2Cleared 510(K)
- K971475SHIELDED SURGICAL TROCAR2Cleared 510(K)
- K971850SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES2Cleared 510(K)
- K972504MVM 3.3 MM MICROENDOSCOPE2Cleared 510(K)
- K971738ENDOPATH RESPOSABLE TROCAR SYSTEM2Cleared 510(K)
- K965001INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR2Cleared 510(K)
- K972056STANDARD ENDOSCOPE2Cleared 510(K)
- K971334PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR2Cleared 510(K)
- K970917SOLOS 10MM OPERATING LAPAROSCOPE2Cleared 510(K)
- K970900INSTRUMENT HOLDER2Cleared 510(K)
- K9706053-CCD DIGITAL CAMERA2Cleared 510(K)
- K970949SMITH & NEPHEW MIS INSTRUMENTS2Cleared 510(K)
- K970754INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP2Cleared 510(K)
- K970369VISTA MINI CAMERA SYSTEM2Cleared 510(K)
- K9702143 DIMENSIONAL VIDEO ENDOSCOPE2Cleared 510(K)
- K963126AESOP SYSTEM AND ACCESSORIES2Cleared 510(K)
- K961343MEDVISION PERSONAL MONITOR2Cleared 510(K)
- K964930STRYKER SAPHENOUS VEIN HARVEST SCOPE2Cleared 510(K)
- K962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA2Cleared 510(K)
- K964171VASOVIEW BALLOON DISSECTION SYSTEM2Cleared 510(K)
- K963115TROCAR CANNULA2Cleared 510(K)
- K970054TANDEMRX2Cleared 510(K)
- K964672SUTURE APPLICATOR2Cleared 510(K)
- K970056SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES2Cleared 510(K)
- K964258INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 87812Cleared 510(K)
- K963919LSI VIDEOSCOPIC DISPLAY SYSTEM2Cleared 510(K)
- K963760NON-SHIELDED SURGICAL TROCAR AND SLEEVE2Cleared 510(K)
- K963184OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM2Cleared 510(K)
- K964123REUSABLE TROCAR WITH SLEEVE (COMMON)2Cleared 510(K)
- K964334EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)2Cleared 510(K)
- K963323ENDO VIP2Cleared 510(K)
- K963815REUSABLE TROCAR WITH SLEEVE (COMMON)2Cleared 510(K)
- K963046ENDOCAM2Cleared 510(K)
- K963329ETHICON ENDOSUTURE SYSTEM2Cleared 510(K)
- K962684S-357 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K962799MINIATURE LAPAROSCOPE SET (MINI LAP)2Cleared 510(K)
- K961463HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-22Cleared 510(K)
- K962651S-52 ELECTRONIC VIDEO LAPAROSCOPE2Cleared 510(K)
- K960301ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR2Cleared 510(K)
- K962104AIRLIFT BALLOON RETRACTON SYSTEM2Cleared 510(K)
- K961800HEAD MOUNTED DISPLAY2Cleared 510(K)
- K962020S-41 & S-41S VIDEO IMAGING SYSTEM2Cleared 510(K)
- K962193PORTLAND TROCARS2Cleared 510(K)
- K960903KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY2Cleared 510(K)
- K962005EXTRAHAND BALLOON RETRACTOR2Cleared 510(K)
- K9611823D SCOPE2Cleared 510(K)
- K961940INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP2Cleared 510(K)
- K962147DEXTERITY PNEUMO SLEEVE SET2Cleared 510(K)
- K962395SPECIMEN RETRIEVAL BAG2Cleared 510(K)
- K955845LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS2Cleared 510(K)
- K9606375MM ENDOSCOPE2Cleared 510(K)
- K961430INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP2Cleared 510(K)
- K961224HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM2Cleared 510(K)
- K961492HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 00260102Cleared 510(K)
- K960655AESOP SYSTEM AND ACCESSORIES2Cleared 510(K)
- K960562GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 60052Cleared 510(K)
- K961175TROGARD TROCAR DIALATING TROCAR SYSTEM2Cleared 510(K)
- K960748MODIFIED HAND INSTRUMENT DEVICES2Cleared 510(K)
- K955076SAFE TEE2Cleared 510(K)
- K960232ENDOSCOPIC ACCESS DEVICE2Cleared 510(K)
- K960883INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX82Cleared 510(K)
- K960878MAHLER ABDOMINAL WALL ELEVATOR2Cleared 510(K)
- K954864ASLAN MODULAR INSTRUMENT2Cleared 510(K)
- K953419LOS 3D VISION 1002Cleared 510(K)
- K955404OTV-S5 OES VIDEO SYSTEM2Cleared 510(K)
- K955408MICROSURGE THORACOSCOPIC INSTRUMENTS2Cleared 510(K)
- K955490LAPAROSCOPIC KNITTER2Cleared 510(K)
- K952959THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK2Cleared 510(K)
- K952906THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK2Cleared 510(K)
- K954649WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP2Cleared 510(K)
- K954853AUTO SUTURE SUTURE CLOSURE2Cleared 510(K)
- K9433073D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY2Cleared 510(K)
- K954160MSV-2000 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K952958THE TULIP COMPANY BRANSON OVERSHEATH2Cleared 510(K)
- K952932THE TULIP COMPANY BRANSON #1 ELEVATOR2Cleared 510(K)
- K952951THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR2Cleared 510(K)
- K952953THE TULIP CXOMPANY BRANSON #2 ELEVATOR2Cleared 510(K)
- K952901THE TULIP COMPANY BRANSON #1 & #2 ELEVATOR2Cleared 510(K)
- K952902THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR2Cleared 510(K)
- K954174DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]2Cleared 510(K)
- K954175DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]2Cleared 510(K)
- K953438SURGICAL INTEGRATED CAMERA SYSTEM2Cleared 510(K)
- K954089ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE2Cleared 510(K)
- K952936THE TULIP COMPANY BRANSON ANTERIOR ELEVATOR2Cleared 510(K)
- K952934THE TULIP COMPANY BRANSON RECURVED DISSECTOR2Cleared 510(K)
- K952957THE TULIP INSULATED GRASPERS2Cleared 510(K)
- K952956THE TULIP COMPANY BRANSON DOUBLE-ENDED DISSECTOR2Cleared 510(K)
- K952955THE TULIP COMPANY BRANSON STRAIGHT DISSECTOR2Cleared 510(K)
- K952954THE TULIP COMPANY WEIL-BLAKESLEY FORCEPS2Cleared 510(K)
- K952899THE TULIP INSULATED SCISSORS2Cleared 510(K)
- K952900THE TULIP COMPANY BRANSON SOFT TISSUE RETRACTOR2Cleared 510(K)
- K954072MICROSURGE PUNCTURE CLOSE DEVICE2Cleared 510(K)
- K953377DISTENTION BALLOON2Cleared 510(K)
- K953903LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM2Cleared 510(K)
- K954108MODIFIED VERSAPORT2Cleared 510(K)
- K953409LAPAROSCOPIC TROCAR2Cleared 510(K)
- K953418ELECTROCAUTERY SHROUD2Cleared 510(K)
- K9516463DSEE2Cleared 510(K)
- K953410BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR2Cleared 510(K)
- K953121MICROSURGE THORACOSCOPIC ACCESS SYSTEM2Cleared 510(K)
- K952980THE TULIP LARGE SOFT TISSUE RETRACTOR2Cleared 510(K)
- K952935THE TULIP SMALL SOFT TISSUE RETRACTOR2Cleared 510(K)
- K953086WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA2Cleared 510(K)
- K952965THE TULIP J DISSECTOR2Cleared 510(K)
- K953611DEXIDE ENDO-LUBE KIT2Cleared 510(K)
- K951482ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)2Cleared 510(K)
- K953376ACCESS POINT2Cleared 510(K)
- K953348ARTICULATING RETRACTOR TISSUE RETRACTORS2Cleared 510(K)
- K954011FASCIA CLOSURE DEVICE2Cleared 510(K)
- K953123QUIK-STITCH2Cleared 510(K)
- K951990LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE2Cleared 510(K)
- K951996IMAGYN ENDOSCOPE2Cleared 510(K)
- K953440ELLMAN LAPTRODE2Cleared 510(K)
- K953243LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH2Cleared 510(K)
- K951974IMAGYN ENDOSCOPE SHEATH2Cleared 510(K)
- K953549KSEA EXTRACTION BAG2Cleared 510(K)
- K953509BIPOLAR COAGULATING FORCEPS2Cleared 510(K)
- K953481NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER2Cleared 510(K)
- K953561PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)2Cleared 510(K)
- K952443KARL STORZ ENDOSCOPY POWDER BLOWER2Cleared 510(K)
- K952444SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II SURGICAL BALLOON DISSECTOR WITH CANNULA2Cleared 510(K)
- K952278THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA2Cleared 510(K)
- K952926QUESTUS DISPOSABLE ENDOSCOPIC KNIFE2Cleared 510(K)
- K952842ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE2Cleared 510(K)
- K952785BRIMFIELD PRECISION DETACHABLE SCISSOR2Cleared 510(K)
- K942910DEEPVISON2Cleared 510(K)
- K952977SABRE MULTI-USE TROCAR SYSTEM2Cleared 510(K)
- K952814ETHICON ARTHROSCOPIC KNOT PUSHER2Cleared 510(K)
- K952723DEVMED REUSEABLE TROCAR SYSTEM2Cleared 510(K)
- K951090INTRODUCER2Cleared 510(K)
- K951386COMBINATION CAMERA/LIGHT SOURCE2Cleared 510(K)
- K951878SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA2Cleared 510(K)
- K951546ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS2Cleared 510(K)
- K932033LAPAROSCOPIC SURGERY INSTRUMENTS2Cleared 510(K)
- K951522WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA2Cleared 510(K)
- K952264ASLAN LAPRETRACT2Cleared 510(K)
- K951986INSULATED ELECTROSURGICAL INSTRUMENTS2Cleared 510(K)
- K952421NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS2Cleared 510(K)
- K951733NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS2Cleared 510(K)
- K950702LAPAROSCOPIC CLAMP2Cleared 510(K)
- K950862KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURES2Cleared 510(K)
- K951625KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT2Cleared 510(K)
- K950753CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO2Cleared 510(K)
- K951715ENDO IRRIGATOR 2211, INCLUDING TUBING2Cleared 510(K)
- K950632INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP2Cleared 510(K)
- K950658INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:2Cleared 510(K)
- K951535KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS2Cleared 510(K)
- K950959TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE2Cleared 510(K)
- K950562IMPLANTABLE STAPLE2Cleared 510(K)
- K950502CCD ENDOCAM 55012Cleared 510(K)
- K951692MIST ENDOSCOPIC PROBES2Cleared 510(K)
- K951481MIST ENDOSCOPIC CANNULAS2Cleared 510(K)
- K951480MIST TROCARS2Cleared 510(K)
- K951398MIST REDUCER SLEEVES2Cleared 510(K)
- K951444ENDOPATH OPTICAL ACCESS NEEDKLE2Cleared 510(K)
- K951252KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME2Cleared 510(K)
- K950612ENDOSCOPES AND ACCESSORIES2Cleared 510(K)
- K950726TSI WILLEN-REICH NEEDLE2Cleared 510(K)
- K950126ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE2Cleared 510(K)
- K951387SYMBIOSIS BIPOLAR SCISSORS2Cleared 510(K)
- K950339KSEA STEINER ELECTROMECHANIC MORCELLATOR2Cleared 510(K)
- K950243TITAN INSUFFLATION NEEDLE2Cleared 510(K)
- K951251KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE2Cleared 510(K)
- K944309M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM2Cleared 510(K)
- K950021REUSABLE TROCAR WITH SAFETY SLEEVE2Cleared 510(K)
- K950985ZEISS ENDOLIVE STERO ENDOSCOPE2Cleared 510(K)
- K950277INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER2Cleared 510(K)
- K950811KARL STORZ FIBER OPTIC LIGH CABLES2Cleared 510(K)
- K951173MANUAL SURGICAL INSTRUMENT FOR GENERAL USE2Cleared 510(K)
- K951082CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE2Cleared 510(K)
- K951086NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES2Cleared 510(K)
- K951060KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRN2Cleared 510(K)
- K950745CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES)2Cleared 510(K)
- K950747CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)2Cleared 510(K)
- K950748CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE)2Cleared 510(K)
- K950744CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)2Cleared 510(K)
- K950746CHAKOFF ENDOSCOPY (SET LAPAROSCOPY)2Cleared 510(K)
- K950103LAPAROSCOPE, HAND INSTRUMENTS2Cleared 510(K)
- K946089NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA2Cleared 510(K)
- K950297ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM2Cleared 510(K)
- K950076LAPAROSCOPE2Cleared 510(K)
- K945953GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)2Cleared 510(K)
- K943554DOFI RASTER-SCREEN2Cleared 510(K)
- K950503MANUAL SURGICAL INSTRUMENT FOR GENERAL USE2Cleared 510(K)
- K950500BASIC REUSABLE TROCAR SYSTEM2Cleared 510(K)
- K945862ENDCUP2Cleared 510(K)
- K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES2Cleared 510(K)
- K945890KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER2Cleared 510(K)
- K950336KARL STORZ ADAPTERS FOR DOCUMENTATION PURPOSES2Cleared 510(K)
- K950378ARGUS LAPAROSCOPY INSTRUMENT SYSTEM2Cleared 510(K)
- K950198MANUAL SURGICAL INSTRUMENT FOR GENERAL USE2Cleared 510(K)
- K950214ABDOMINAL WALL RETRACTOR2Cleared 510(K)
- K946330KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR2Cleared 510(K)
- K950286SYMBIOSIS BIPOLAR SCISSORS2Cleared 510(K)
- K950278MINI LAPAROSCOPY FOR GENERAL SURGERY2Cleared 510(K)
- K950170CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE2Cleared 510(K)
- K950231LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY2Cleared 510(K)
- K946239ENDOXFLEX 50002Cleared 510(K)
- K950063WGL ENDOSCOPIC GRASPER*2Cleared 510(K)
- K946241ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR2Cleared 510(K)
- K946213KSEA STEINER ELECTROMECHANIC MORCELLATORT2Cleared 510(K)
- K945520HEMOCLIP ECOSYSTEM2Cleared 510(K)
- K945394INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER2Cleared 510(K)
- K946263BRIMFIELD PRECISION GRASPER/DISSECTOR2Cleared 510(K)
- K946171VIDEO ENDOSCOPE SYSTEM WITH ZOOM2Cleared 510(K)
- K950005TROCAR CANNULA STABILIZER2Cleared 510(K)
- K946164KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS2Cleared 510(K)
- K945170QUIK-STITCH2Cleared 510(K)
- K941222OPEN LAPAROSCOPY TROCAR CONE SYSTEM2Cleared 510(K)
- K945545ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K943614A.W.E.L.2Cleared 510(K)
- K942601PSI FLEXIBLE ARM2Cleared 510(K)
- K945979TROCAR/CANNULA2Cleared 510(K)
- K946023KARL STORZ TELESCOPE BRIDGES AND ADAPTERS2Cleared 510(K)
- K945297INFRA VISION IMAGING SYSTEM2Cleared 510(K)
- K945751KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES2Cleared 510(K)
- K945263OPTUS THORACOSCOPES2Cleared 510(K)
- K942168WGL ENDOSCOPIC GRASPER2Cleared 510(K)
- K944299KARL STORZ INSULATED BIOPSY FORCEPS2Cleared 510(K)
- K945637R-MED MOTORIZED LAPAROSCOPIC HANDLE2Cleared 510(K)
- K944672INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES2Cleared 510(K)
- K945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER2Cleared 510(K)
- K944303COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER2Cleared 510(K)
- K944201HI-Q HAND INSTRUMENTS- UROLOGY2Cleared 510(K)
- K945457TROCAR ( ACCESORY)2Cleared 510(K)
- K945369LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE2Cleared 510(K)
- K941348KRONNER LAPAROSCOPIC HOLDER2Cleared 510(K)
- K945101KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD2Cleared 510(K)
- K945059KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS2Cleared 510(K)
- K944974ACCESS POINT2Cleared 510(K)
- K944954ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS2Cleared 510(K)
- K940960SUCTION AND IRRIGATION TUBES2Cleared 510(K)
- K943435CHOLANGIOGRAPHY SET2Cleared 510(K)
- K943327CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS2Cleared 510(K)
- K945023ORIGIN PIXIE STIC INTRODUCER SLEEVE2Cleared 510(K)
- K940790BABCOCK/BOWEL CLAMP FORCEPS2Cleared 510(K)
- K944870JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-6802Cleared 510(K)
- K944418THE SPACEMAKER AND THE SPACEMAKER II2Cleared 510(K)
- K943253INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.2Cleared 510(K)
- K943502UNIGRIP2Cleared 510(K)
- K944536GSI KNOTMAKER2Cleared 510(K)
- K944467AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K942924MSV-2000 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K944465CARRIER, LIGATURE (79 GEJ)2Cleared 510(K)
- K942574GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER2Cleared 510(K)
- K944414DEKALB2Cleared 510(K)
- K943056SINGLE STICK RADIALLY EXPANDING DILATOR2Cleared 510(K)
- K944304ORIGIN BALLOON ANCHOR2Cleared 510(K)
- K942306IRRIGATION/ASPIRATION INSTRUMENT2Cleared 510(K)
- K944224KARL STORZ FLUID LIGHT CABLES2Cleared 510(K)
- K943927END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM2Cleared 510(K)
- K935277KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH2Cleared 510(K)
- K943786PORTLAND TROCARS2Cleared 510(K)
- K944082ASLAN DUAL ACTION JAWS GRASPING FORCEPS2Cleared 510(K)
- K940731INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES2Cleared 510(K)
- K944103LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT2Cleared 510(K)
- K935279KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE2Cleared 510(K)
- K943976SABRE ULTIMATE SHIELDED TROCAR2Cleared 510(K)
- K943958MONOPOLAR ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS2Cleared 510(K)
- K940427KARL STORZ THORACIC SURGERY INSTRUMENTS2Cleared 510(K)
- K943970DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE2Cleared 510(K)
- K934704AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH2Cleared 510(K)
- K935270MODULAR FORCEP AND SCISSOR SYSTEM2Cleared 510(K)
- K942817CCD ENDOCAM OFFICE 55102Cleared 510(K)
- K942819TROCAR WITH SHIELD2Cleared 510(K)
- K942740SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM2Cleared 510(K)
- K941027ENDOPATH OPTICAL OBTURATOR AND SLEEVE2Cleared 510(K)
- K942703GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA2Cleared 510(K)
- K941401MILL ROSE ERCP CANNULAS2Cleared 510(K)
- K936195LAPAROSCOPES2Cleared 510(K)
- K942612KARL STORZ WOUND CLOSURE INSTRUMENTS2Cleared 510(K)
- K942597CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR2Cleared 510(K)
- K941950OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 3602Cleared 510(K)
- K943671GSI CANNULA REDUCER ACCESSORY2Cleared 510(K)
- K943489DISPOSABLE SURGICAL TROCAR2Cleared 510(K)
- K942358AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA2Cleared 510(K)
- K943117INTRA-SONIX UROFIBER2Cleared 510(K)
- K943172CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR2Cleared 510(K)
- K942839OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY2Cleared 510(K)
- K943070REUSABLE PROBES2Cleared 510(K)
- K940948ANGLED DISSECTORS MODELS 8383.581/582/5712Cleared 510(K)
- K935243AESCULAP FLEXIBLE TROCAR INSTRUMENT SET2Cleared 510(K)
- K942879DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH2Cleared 510(K)
- K941773MEDICAM 900 REMOTE2Cleared 510(K)
- K942678LIFTING DISTENTION BALLOON SYSTEM2Cleared 510(K)
- K942641SURGIN IRRIGATION PUMP2Cleared 510(K)
- K942491ORIGIN BALLOON RETRACTOR2Cleared 510(K)
- K941249SPECIMEN REMOVAL DEVICE2Cleared 510(K)
- K941747SURGISTAR TROCARS2Cleared 510(K)
- K936262DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS2Cleared 510(K)
- K930224STRYKER ARTHROSCOPIC ACCESSORIES2Cleared 510(K)
- K941693MEDICAM ENDOCOUPLER AND BEAMSPLITTER2Cleared 510(K)
- K942584PUTMAN STABILIZER2Cleared 510(K)
- K942414TROCAR SLEEVE, SEALING CAPS, REDUCER, LOOP GUIDE2Cleared 510(K)
- K942415R-BAR RETRACTOR2Cleared 510(K)
- K942053AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET2Cleared 510(K)
- K940988ACCESSORIES, SURGICAL CAMERA2Cleared 510(K)
- K933750MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIF2Cleared 510(K)
- K941390DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE2Cleared 510(K)
- K942416HASSON GRASPERS2Cleared 510(K)
- K932626CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB2Cleared 510(K)
- K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K941136KNOT SLIDE 8383.55 AND 8383.5512Cleared 510(K)
- K940347TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES2Cleared 510(K)
- K942202SUCTION AND IRRIGATION TUBES2Cleared 510(K)
- K942201LAPAROSCOPY DILATION SYSTEM2Cleared 510(K)
- K941286SUTURE MANIPULATOR2Cleared 510(K)
- K940141LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH2Cleared 510(K)
- K935786CORSON AND NEZHAT SUCTION/IRRIGATION PROBES2Cleared 510(K)
- K940011MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM2Cleared 510(K)
- K935826LAPAROSCOPIC/SUCTION/IRRIGATION PROBE2Cleared 510(K)
- K936102DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES2Cleared 510(K)
- K941967HSW LAPAROSCOPE AND ACCESSORIES2Cleared 510(K)
- K941541HSV LAPAROSCOPY SET2Cleared 510(K)
- K936248MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS2Cleared 510(K)
- K936279GALILEO ENDOSCOPES2Cleared 510(K)
- K930667REUSABLE LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K940346SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES2Cleared 510(K)
- K936250RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP2Cleared 510(K)
- K935986GORE LAPAROSCOPIC SUTURE PASSER2Cleared 510(K)
- K933497LAPAROSCOPIC COVERED SURGICAL RETRACTOR2Cleared 510(K)
- K932553DISPOSABLE SUTURE PLACEMENT SYSTEM2Cleared 510(K)
- K941250TROCAR AND CANNULA2Cleared 510(K)
- K934916CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS2Cleared 510(K)
- K933458SURGICAL TROCARS2Cleared 510(K)
- K940875ADJUSTABLE BALLOON DISSECTION CANNULA2Cleared 510(K)
- K935754MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER2Cleared 510(K)
- K941276BRIMFIELD PRECISION SECOND GENERATION GRASPER/DISSECTOR2Cleared 510(K)
- K940551ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K940431TECNADYNE 20/20 FOG INHIBITOR KIT2Cleared 510(K)
- K924792MULTIPLE PURPOSE FORCEPS2Cleared 510(K)
- K940891TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER2Cleared 510(K)
- K940428INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR2Cleared 510(K)
- K940157ENLINE MONOPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K935071INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS2Cleared 510(K)
- K932987BIRTCHER LAPAROSCOPE AND ACCESSORIES2Cleared 510(K)
- K930887BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)2Cleared 510(K)
- K936114BIRTCHER PERICARDIAL KNIVES2Cleared 510(K)
- K941316BRIMFIELD PRECISION FAN RETRACTOR2Cleared 510(K)
- K935207ENDOFLUSH SYSTEM 1.0, 2.O, 3.02Cleared 510(K)
- K940900APPENDIX EXTRACTOR 8385.502Cleared 510(K)
- K941500TISSUE ISOLATION AND RETRIEVAL BAG2Cleared 510(K)
- K933169INMAN ENDOSCOPIC BLUNT DISSECTOR2Cleared 510(K)
- K940232INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.2Cleared 510(K)
- K941024AESCULAP TROCAR COLLAR2Cleared 510(K)
- K940241ACUFEX VIDEO SYSTEM2Cleared 510(K)
- K931778LAPAROSCOPY INSTRUMENTS2Cleared 510(K)
- K941092MURDOCH LAPAROSCOPE LENS CLEANER2Cleared 510(K)
- K930965LOS 3D VISION 1002Cleared 510(K)
- K940398AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II2Cleared 510(K)
- K931850VERRSS PNEUMO NEEDLE2Cleared 510(K)
- K936097VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL2Cleared 510(K)
- K930813PISTOL SUCTION/IRRIGATION PROBE2Cleared 510(K)
- K940199DISSECTOR2Cleared 510(K)
- K940155ENLINE ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K932060MARTIN COLD LIGHT FOUNTAIN2Cleared 510(K)
- K940587FLEX-I-PORT2Cleared 510(K)
- K940439GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT2Cleared 510(K)
- K931879REFLEX HTR2Cleared 510(K)
- K930254DAVIS+GECK REUSABLE TRTOCARS2Cleared 510(K)
- K925958SCISSOR FOR LAPAROSCOPIC SURGERY GU USE2Cleared 510(K)
- K935604LASERSONICS TISSUE MORCELLATOR SET2Cleared 510(K)
- K934937KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC2Cleared 510(K)
- K935109SDR (SOFT DISSECTOR RAKE)2Cleared 510(K)
- K940688TROCAR TUBE2Cleared 510(K)
- K935234STRYKER ENDOSCOPIC VIDEO ACCESSORIES2Cleared 510(K)
- K934155WATTS RAKE WITH LEUR PORT & AQUA-PROBE TIP2Cleared 510(K)
- K934153WATTS RAKE WITH LEUR LOCK PORT2Cleared 510(K)
- K940687TROCAR2Cleared 510(K)
- K933776OPTIK LAPAROSCOPE2Cleared 510(K)
- K935442MAHE INSTRUMENTS2Cleared 510(K)
- K935115EEC PROBE2Cleared 510(K)
- K934737LASSO (SCHWAITZBERG) SUTURE SNARE2Cleared 510(K)
- K935645FLOWGUN REUSABLE IRRIGATION PROBES2Cleared 510(K)
- K932617S*E*M*M-SET & C*U*R*T-SET2Cleared 510(K)
- K932696ISI(R) CURVED, TAPERED DISSECTING FORCEPS2Cleared 510(K)
- K932695ISI(R) PORPOISE NOSE DISSECTING FORCEPS2Cleared 510(K)
- K934807PUNCTURE CLOSURE DEVICE2Cleared 510(K)
- K930848SENSING TIP SURGICAL TROCAR2Cleared 510(K)
- K926479BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM2Cleared 510(K)
- K934527FASCIA STITCHER2Cleared 510(K)
- K926080DMI LAPAROSCOPIC IRRIGATION PUMP2Cleared 510(K)
- K933345NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC2Cleared 510(K)
- K933353IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES2Cleared 510(K)
- K931425SURGICAL PATCH SPREADER2Cleared 510(K)
- K934547MECTRA TROCAR2Cleared 510(K)
- K934094STRYKER LAPAROSCOPIC SUCTION IRRIGATOR2Cleared 510(K)
- K925499LAPROSCOPIC/ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K940259STERILE TROCAR AND 5.7MM SLEEVE2Cleared 510(K)
- K935086AUTO SUTURE DISPOSABLE OPTICAL TROCAR2Cleared 510(K)
- K934750YANKAUER WITH CONNECTING TUBING2Cleared 510(K)
- K9345115,6,7,9,10,11&12MM BLUNT-TIPPED TROCAR OBTURATORS2Cleared 510(K)
- K932540LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE2Cleared 510(K)
- K9345282C LENS FOG REDUCTION & CLEANING DEVICE2Cleared 510(K)
- K940193SURGICAL RETRACTOR KIT2Cleared 510(K)
- K935382GRASPERS2Cleared 510(K)
- K935293FLUID ASPIRATION NEEDLE2Cleared 510(K)
- K930607GRIPPER2Cleared 510(K)
- K934398ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE2Cleared 510(K)
- K934338INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION2Cleared 510(K)
- K935878GLASSER SUTURE NEEDLE2Cleared 510(K)
- K934097I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA2Cleared 510(K)
- K936154LAPAROSCOPIC TROCAR STARTER SCALPEL2Cleared 510(K)
- K935999DAVINCI RECONFIGURABLE LAPAROSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K932627CHAKOFF ENDOSCOPY2Cleared 510(K)
- K933075LAPAROSCOPIC RETRACTOR2Cleared 510(K)
- K931522FASCIAL CLOSURE DEVICE2Cleared 510(K)
- K930180BIOPSY CUP FORCEPS2Cleared 510(K)
- K932796OWENS TROCAR2Cleared 510(K)
- K932441SERIES 8920 TROCAR SYSTEM2Cleared 510(K)
- K935709GENERAL SURGERY PROBE/GENERAL SURGERY PROBE W/DISTAL PERFORATIONS2Cleared 510(K)
- K935762AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE2Cleared 510(K)
- K935073NON-INSULATED SCISSORS2Cleared 510(K)
- K933067PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS2Cleared 510(K)
- K935426PREPERITONEAL DISTENTION BALLOON SYSTEM2Cleared 510(K)
- K934157HYDRO-PROBE2Cleared 510(K)
- K9341585MM CALIBRATED SUCTION CANNULA2Cleared 510(K)
- K934165STERILE, DISPOSABLE ENDO SPECIEMEN RETRIEVAL BAG2Cleared 510(K)
- K934077PHX TECHOLOGIES CORP., 5MM STERILE, DISPOSABLE ENDOSCOPIC KITTNER BLUNT DISSECTING INSTRUMENT2Cleared 510(K)
- K933725ENDOSCOPIC NEEDLE DRIVER2Cleared 510(K)
- K933025LAPORASCOPIC CANNULA SEAL2Cleared 510(K)
- K934347ANTIFOG2Cleared 510(K)
- K934280PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE2Cleared 510(K)
- K934279PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS AND MATCHED TROCAR TUBES2Cleared 510(K)
- K932346AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K9337905MM DISPOSABLE SUCTION-IRRIGATION CANNULA2Cleared 510(K)
- K93378910MM DISPOSABLE, STERILE SUCTION CANNULA2Cleared 510(K)
- K933895PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE2Cleared 510(K)
- K933724SENSOR-TIP TROCAR2Cleared 510(K)
- K932692INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT2Cleared 510(K)
- K934739DAVINCI CHOLANGIOGRAM DELIVERY DEVICE2Cleared 510(K)
- K934163WATTS RAKE DEVICE2Cleared 510(K)
- K933834AESCULAP RIGID ENDOSCOPES2Cleared 510(K)
- K934078PHX TECHNOLOGIES CORP.,10MM STERILE, DISPOSABLE POOL TIP SUCTION CANNULA2Cleared 510(K)
- K934023PHX TECHNOLOGIES CORP., ALTRAUMATIC GRASPER DEVICE2Cleared 510(K)
- K934022PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER2Cleared 510(K)
- K934021PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE2Cleared 510(K)
- K934025PHX TECHNOLOGIES CORP, SPONGE GRASPER DEVICE2Cleared 510(K)
- K934026PHX TECHNOLOGIES CORP. BOWEL GRASPER DEVICE2Cleared 510(K)
- K934027PHX TECHNOLOGIES CORP., ALLIGATOR GRASPER DEVICE2Cleared 510(K)
- K934024PHX TECHNOLOGIES CORP., SUTURE GRASPER DEVICE2Cleared 510(K)
- K926181ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY2Cleared 510(K)
- K934185TROCAR REDUCER WITH GAS CLHECK VALVE2Cleared 510(K)
- K934098STERILE, DISPOSABLE ENDOSCOPIC TRUMPET VALVE2Cleared 510(K)
- K933812ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES2Cleared 510(K)
- K931962NON-ABSORBABLE GAUZE2Cleared 510(K)
- K933897PHX TECHNOLOGIES CORP., 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA CLEANER2Cleared 510(K)
- K933896PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER2Cleared 510(K)
- K932321LAPAROSCOPY OPTICS2Cleared 510(K)
- K934534TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION2Cleared 510(K)
- K934173SUTURE HANDLER2Cleared 510(K)
- K933536CARTER-THOMASON NEEDLE-POINT SUTURE PASSER2Cleared 510(K)
- K931783AESOP (AUTOMATED ENDOSCOPIC SYSTEM FOR OPTIMAL POS2Cleared 510(K)
- K934725PHX TECHNOLOGIES CORP., ISDS-2000, IRRIGATION SOLUTION DELIVERY SYSTEM2Cleared 510(K)
- K934076PHX TECHNOLOGIES CORP., IRRIGATION SOLUTION DELIVERY SYSTEM, ISDS-10002Cleared 510(K)
- K933192ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.2Cleared 510(K)
- K932631XENON LIGHT SOURCE ILLUMINATOR2Cleared 510(K)
- K932629FIBER OPTIC LIGHT CABLE2Cleared 510(K)
- K933985MICROWAVE INSURG INTRODUCER2Cleared 510(K)
- K933720INSTRUMENT ACTUATING DEVICE (IAD)2Cleared 510(K)
- K926016NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE2Cleared 510(K)
- K925959FORCEPS FOR LAPAROSCOPIC SURGERY GU USE2Cleared 510(K)
- K932697ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR2Cleared 510(K)
- K931928JARIT SURGICAL INSTRUMENTS2Cleared 510(K)
- K933456COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE2Cleared 510(K)
- K933421ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES2Cleared 510(K)
- K932979EXTERNAL STABILITY PAD2Cleared 510(K)
- K932698ISI(R) HOOK SUTURES SCISSORS2Cleared 510(K)
- K933388BRIMFIELD PRECISION SCISSOR2Cleared 510(K)
- K933243KNOT PUSHER2Cleared 510(K)
- K933909SCOPE WASH2Cleared 510(K)
- K933387BRIMFIELD PRECISION GRASPER/DISSECTOR2Cleared 510(K)
- K926480LAPAROSCOPIC BALLOON RETRACTOR2Cleared 510(K)
- K932648QUICK SWITCH LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K922608ENDOPATH EP DISPOSABLE TROCAR2Cleared 510(K)
- K930605APPLIER, SURGICAL, CLIP2Cleared 510(K)
- K934134DISTENTION INSTRUMENT, MODIFICATION2Cleared 510(K)
- K933160PROCEDURE KITS2Cleared 510(K)
- K932885AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP2Cleared 510(K)
- K932995SURGICAL TROCAR AND CANNULA2Cleared 510(K)
- K932045DISPOSABLE INSUFFLATION TUBING2Cleared 510(K)
- K923201ENDOSI SUCTION IRRIGATOR2Cleared 510(K)
- K933104ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG2Cleared 510(K)
- K933076AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K933032LAPAROSCOPIC SURGICAL RETRACTOR2Cleared 510(K)
- K921103RETRACTION INSTRUMENT2Cleared 510(K)
- K932976CABOT MEDICAL OPTIMA HAND INSTRUMENTS2Cleared 510(K)
- K932977CABOT MEDICAL OPTIMA HAND INSTRUMENTS2Cleared 510(K)
- K931895ENDOSCOPE ACCESSORY2Cleared 510(K)
- K931138CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP2Cleared 510(K)
- K930463LOCKING PIVOTAL THORACOPORT2Cleared 510(K)
- K933009SURGICAL RETRACTOR/BLUNT DISSECTOR2Cleared 510(K)
- K925382CUTTER, SURGICAL2Cleared 510(K)
- K933661INSUFFLATOR TUBING KIT W/FILTER2Cleared 510(K)
- K933520ENDOSCOPIC ANTI-FOG KIT, 100-302-002Cleared 510(K)
- K933049SRUGICAL RETRACTOR, MODIFICATION2Cleared 510(K)
- K931878JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 6802Cleared 510(K)
- K932229SURGICAL TROCAR AND TROCAR SLEEVE2Cleared 510(K)
- K931518IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE2Cleared 510(K)
- K93280510.0MM SUCTION/IRRIGATION PROBE & TUBING KIT2Cleared 510(K)
- K932804IRRIGATING TAPERED PROBE2Cleared 510(K)
- K932806POOLE TIP SUCTION PROBE & TUBING KIT2Cleared 510(K)
- K931273MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPIC2Cleared 510(K)
- K930617OBGRIP AND UNITIPS(TM)2Cleared 510(K)
- K933416DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH2Cleared 510(K)
- K932604UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC2Cleared 510(K)
- K930809UNITIPS2Cleared 510(K)
- K925917UNICHANNEL(TM SURGICAL GRASPER2Cleared 510(K)
- K925882UNITIPS SURGICAL INSTRUMENTS2Cleared 510(K)
- K932466MEDCHEM SURGICAL DELIVERY SYSTEM2Cleared 510(K)
- K931707ENDOSCOPIC CABLE/WIRE COVER2Cleared 510(K)
- K931706ENDOSCOPIC CABLE DRAPE2Cleared 510(K)
- K931649LAPAROSCOPIC BALLOON RETRACTOR2Cleared 510(K)
- K931262REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR2Cleared 510(K)
- K926583REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR2Cleared 510(K)
- K931275MIST MICROSURGICAL MONOPOLAR FORCEPS2Cleared 510(K)
- K931274MIST MICROSURGICAL MONOPOLAR SCISSORS2Cleared 510(K)
- K924372LAPAROSCOPIC NERVE HOOK2Cleared 510(K)
- K932022ENTREE THORACOSCOPY CANNULA SET2Cleared 510(K)
- K931898ENDOSWAB2Cleared 510(K)
- K931223FUJINON VIDEO LAPAROSCOPE--THORACOSCOPY2Cleared 510(K)
- K930817LAPAROSCOPIC LYMPHADENECTOMY2Cleared 510(K)
- K925599FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE2Cleared 510(K)
- K931281MICRO ENDOSCOPIC ELECTRODE (ME2)2Cleared 510(K)
- K931278INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR2Cleared 510(K)
- K930716LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION2Cleared 510(K)
- K930572NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP2Cleared 510(K)
- K926089KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER2Cleared 510(K)
- K931705ENDOSCOPIC INSTRUMENT HOLDER2Cleared 510(K)
- K930462ENDOSCOPIC UMBRELLA RETRACTOR2Cleared 510(K)
- K925624MICROSURGICAL INSTRUMENTS2Cleared 510(K)
- K930301TROCAR SHEATH ANCHOR2Cleared 510(K)
- K924011ORIGIN BLUNT TIP SURGICAL TROCAR2Cleared 510(K)
- K926110ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT2Cleared 510(K)
- K925602DAVIS+GECK ABSORBABLE LIGATING DEVICE2Cleared 510(K)
- K931142INSTRUMENTS FOR LAPAROSCOPIC USE2Cleared 510(K)
- K931018KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES2Cleared 510(K)
- K930511STEALTH SURGICAL IRRIGATOR ASPIRATOR2Cleared 510(K)
- K926444FUJINON VIDEO LAPAROSCOPE, MODIFICATION2Cleared 510(K)
- K926010SURGICAL DISSECTOR WITH CANNULA2Cleared 510(K)
- K925147ORC 10.0MM SUCTION PROBE2Cleared 510(K)
- K924916ENDOPATH ENDOSCOPIC TISSUE RETRACTOR2Cleared 510(K)
- K930550ECO LIGATING CLIP2Cleared 510(K)
- K926335IDEAS PEANUT WAND2Cleared 510(K)
- K932282ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE2Cleared 510(K)
- K931237ENDOPATH* DISPOSABLE INTRODUCER2Cleared 510(K)
- K931238ENDOPATH DISPOSABLE KNOT PUSHER2Cleared 510(K)
- K931111ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULA2Cleared 510(K)
- K930933ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K930147SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY2Cleared 510(K)
- K931259ENDOSCOPIC OR THORASCOPIC FORCEPS2Cleared 510(K)
- K930352HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.2Cleared 510(K)
- K930464BLUNT DISSECTING SCISSORS2Cleared 510(K)
- K930427STD IRRIGATION PUMP2Cleared 510(K)
- K921208ACCU-BEAM TUBE SET2Cleared 510(K)
- K921925MANUAL SURGICAL INSTRUMENTS2Cleared 510(K)
- K930466COMPRESSION CLAMP2Cleared 510(K)
- K930467BABCOCK FORCEPS, GRASPING FORCEPS, NEEDLE HOLDER2Cleared 510(K)
- K930465WIRE GUIDED OVAL DILATORS2Cleared 510(K)
- K931272MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR2Cleared 510(K)
- K926341UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT2Cleared 510(K)
- K926078DMI TOCAR AND CANNULA SYSTEM2Cleared 510(K)
- K925699HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.2Cleared 510(K)
- K924931NEEDLE, PNEUMOPERITONEUM, SPRING LOADED2Cleared 510(K)
- K931276MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPIC2Cleared 510(K)
- K921457IRRIGATION PUMPS AND TUBING AND SUCTION TUBING2Cleared 510(K)
- K925914PRE-TIED LOOP SUTURE CANNULA2Cleared 510(K)
- K931092ENDOSCOPIC RETRACTOR2Cleared 510(K)
- K931337AUTO SUTURE DILATING CANNULA2Cleared 510(K)
- K926214GUIDE WIRE FOR LAPOROSCOPIC USE2Cleared 510(K)
- K930935ENDOPATH TISSUE EXTRACTION CANNULA2Cleared 510(K)
- K925932CANUSEAL2Cleared 510(K)
- K925860MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL2Cleared 510(K)
- K925129SELECTOR2Cleared 510(K)
- K924281HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY2Cleared 510(K)
- K922987LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.2Cleared 510(K)
- K922319OMNI LAPAROSCOPE2Cleared 510(K)
- K930569LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM2Cleared 510(K)
- K926223ENDOSCOPE AND ACCESSORIES2Cleared 510(K)
- K924761STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD2Cleared 510(K)
- K920611MARLOW LAPAROSCOPIC GRASPING FORCEP2Cleared 510(K)
- K930567MODIFIED ENDOSCOPIC CLAMP2Cleared 510(K)
- K926079DMI LAPAROSCOPIC ELECTRODES2Cleared 510(K)
- K924035ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE2Cleared 510(K)
- K923726KENSEY NASH DYNAMIC CLIP SYSTEM2Cleared 510(K)
- K926104POLYP NET2Cleared 510(K)
- K922685TROCARS2Cleared 510(K)
- K920595ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER2Cleared 510(K)
- K924058TROCAR2Cleared 510(K)
- K922797AESCULAP TROCAR INSTRUMENT SET2Cleared 510(K)
- K924022O.R. CONCEPTS SECONDARY CANNULA2Cleared 510(K)
- K922094DISSECTION INSTRUMENT2Cleared 510(K)
- K930082ENDOSCOPE AND ACCESSORIES2Cleared 510(K)
- K923982OLYMPUS OES LAPAROSCOPY SYSTEM2Cleared 510(K)
- K926282MCKERNAN-POTTS GRASPING FORCEPS2Cleared 510(K)
- K926281MCKERNAN-ADSON AGGRESSIVE FORCEPS2Cleared 510(K)
- K921287SURGICAL RETRACTOR2Cleared 510(K)
- K923820LAPAROSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K925824SOLOS FAN RETRACTORS2Cleared 510(K)
- K925669DEVMED LENS WASH SHEATH2Cleared 510(K)
- K925565MAGNETIC RETRIEVER2Cleared 510(K)
- K925410SYMBIOSIS HEMOSTATIC WAND2Cleared 510(K)
- K925198KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR2Cleared 510(K)
- K925267GRASPING FORCEPS OR RETRIEVAL FORCEPS2Cleared 510(K)
- K924284MICROSURGE DIRECTOR ARTICULATING INSTRUMENTS2Cleared 510(K)
- K923547MINIVASIVE LAPAROSCOPY INSTRUMENTS2Cleared 510(K)
- K923945PLEATMAN SAC SPECIMEN CONTAINER2Cleared 510(K)
- K925149AUTO SUTURE ENDOSCOPIC KNOT PUSHER2Cleared 510(K)
- K924149ENDO I/A PROBE2Cleared 510(K)
- K924048CABOT DISPOSABLE 10MM SUCTION DEVICE2Cleared 510(K)
- K923528INLET IRRIGATION/ASPIRATION VALVE AND PROBES2Cleared 510(K)
- K924728KNOT PUSHER2Cleared 510(K)
- K922435LAPAROSCOPIC CURVED TRIANGLE RETRACTOR2Cleared 510(K)
- K921040ENDOSCOPE2Cleared 510(K)
- K924592DAVOL KNOT PUSHER2Cleared 510(K)
- K923219URESIL SPECIMEN RETRIEVAL BAG2Cleared 510(K)
- K925041MCKERNAN ATRAUMATIC FORCEPS2Cleared 510(K)
- K922424ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.2Cleared 510(K)
- K923055OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES2Cleared 510(K)
- K922751ORIGIN FLEXIBLE PORT2Cleared 510(K)
- K921336TROCAR GRASPER/ANVIL APPROXIMATOR2Cleared 510(K)
- K915317PUTMAN STABILIZER2Cleared 510(K)
- K915790ENDO-GARD ELECTROSURGICAL TROCAR2Cleared 510(K)
- K920068AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR2Cleared 510(K)
- K922526DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES2Cleared 510(K)
- K922246TUBING SET W/ IRRIGATION & ASPIRATION VALVING2Cleared 510(K)
- K922405O.R.C. ADAPTER2Cleared 510(K)
- K922571INSTRUMENT, MANUAL, GENERAL SURGICAL2Cleared 510(K)
- K922082LAPAROSCOPIC INTRODUCER2Cleared 510(K)
- K920599HOOK SURGICAL INSTRUMENT2Cleared 510(K)
- K922655SUCTION/IRRIGATION Y TUBING SET2Cleared 510(K)
- K922243E-Z CLAMP#1 AND#22Cleared 510(K)
- K921709ENDOBAG, MODIFICATION2Cleared 510(K)
- K921260LAPAROSCOPIC SURGICAL INSTRUMETNS2Cleared 510(K)
- K921922GRICE LAPAROSCOPIC SUTURING NEEDLE2Cleared 510(K)
- K914752AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS2Cleared 510(K)
- K921086WOM LAPAROFLATOR ELECTRONIC2Cleared 510(K)
- K915372MANUAL SURGICAL INSTRMENTS FOR LAPAROSCOPY2Cleared 510(K)
- K915286LAP TISSUE COLLECTION BAG2Cleared 510(K)
- K914922UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG2Cleared 510(K)
- K914690LM15(TM), CATALOG NUMBER - 5238212Cleared 510(K)
- K915099ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN2Cleared 510(K)
- K915854ENDOSCOPIC TRANSLUMINATOR2Cleared 510(K)
- K915544LAPAROSCOPY SCISSORS2Cleared 510(K)
- K920040INTRADUCER2Cleared 510(K)
- K920403XENON ARC ENDOSCOPE LIGHT SOURCE2Cleared 510(K)
- K915360LAPAROSCOPIC SNARE POUCH2Cleared 510(K)
- K914861EVACUATION KIT #7-510-142Cleared 510(K)
- K915298SUCTION/IRRIGATION CANNULA; CATLOG #532.002Cleared 510(K)
- K912859FUJINON EVL-F2Cleared 510(K)
- K914084ENDOSCOPES2Cleared 510(K)
- K915239ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR2Cleared 510(K)
- K914869MARLOW LAPAROSCOPIC SCISSORS2Cleared 510(K)
- K914919SMITH & NEPHEW DYONICS LAPAROSCOPY SYSTEM2Cleared 510(K)
- K914997ASP-IRRATOR2Cleared 510(K)
- K911730SURGICAL OBTURATOR WITH SEAL2Cleared 510(K)
- K913810HOLMED HAND HELD INSTRUMENTS2Cleared 510(K)
- K913954MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS2Cleared 510(K)
- K914782SUCTION/IRRIGATION PROBE2Cleared 510(K)
- K914781SUCTION/IRRIGATION KITTNER2Cleared 510(K)
- K914549ETHICON ABSORBABLE SUTURE CLIP AND APPLIER2Cleared 510(K)
- K914470PNEUMO-SEAL(TM)2Cleared 510(K)
- K914967SHARP ENDOKNOT PUSHER2Cleared 510(K)
- K914547LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM2Cleared 510(K)
- K914526DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)2Cleared 510(K)
- K912247UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY2Cleared 510(K)
- K913999NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE2Cleared 510(K)
- K914377TROCAR2Cleared 510(K)
- K914098LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR2Cleared 510(K)
- K913762MONOSCOPY(TM) BRAND, ENDOBAG2Cleared 510(K)
- K912492EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE2Cleared 510(K)
- K912933MEDICAM LAPAROSCOPY ENDOSCOPES2Cleared 510(K)
- K914203LAPAROSCOPIC BALLOON RETRACTOR2Cleared 510(K)
- K913991GRASPER, RATCHETED (5MM X 30CM)2Cleared 510(K)
- K913469ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER2Cleared 510(K)
- K912973ENDOSCOPE SUTURE & CARRIER2Cleared 510(K)
- K913500CHERRY SPONGE2Cleared 510(K)
- K912927AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE2Cleared 510(K)
- K912097AUTO SUTURE ENDOSCOPIC FASCIA STAPLER2Cleared 510(K)
- K9138705MM MICROSCISSORS2Cleared 510(K)
- K912556DAVIS AND GECK LAPRO-LOOP LIGATURE CARRIER2Cleared 510(K)
- K913172ENDOSCOPIC DELIVERY SYSTEM2Cleared 510(K)
- K912159MAJOR SET-UP TRAY2Cleared 510(K)
- K912836CANNULA AND TROCAR2Cleared 510(K)
- K912319DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER2Cleared 510(K)
- K912903PERCUTANEOUS RETRACTOR KIT2Cleared 510(K)
- K912862MONOSCOPY(TM) BRANK, HOOK DISSECTOR2Cleared 510(K)
- K911105SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION2Cleared 510(K)
- K912750MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR2Cleared 510(K)
- K913104MONOSCOPY(TM) BRAND, ELECTROSURGICAL RAKE2Cleared 510(K)
- K912980MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED2Cleared 510(K)
- K912579THE VOSS DISPOSABLE SUCTION/IRRIGATION CANNULA2Cleared 510(K)
- K911744PRECISION OPTICS CORPORATION LAPAROSCOPE2Cleared 510(K)
- K912502LAPAROSCOPIC LASER FIBER DIVERTER2Cleared 510(K)
- K911754SCISSORS,GRASPERS,FORCEPS2Cleared 510(K)
- K912605AMCATH DISPOSABLE MICRO SCISSORS2Cleared 510(K)
- K911589DISPOSABLE SURGICAL TROCAR WITH SEAL2Cleared 510(K)
- K911149PAL (PROBE FOR ASPIRATION AND LAVAGE)2Cleared 510(K)
- K911164REICH SUCTION/IRRIGATION CANNULA2Cleared 510(K)
- K910985SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA2Cleared 510(K)
- K911494NEEDLE CANNULA2Cleared 510(K)
- K911490LAPAROSCOPE SUPPORT ARM2Cleared 510(K)
- K911489PALPATATION AND MEASURING STICK2Cleared 510(K)
- K911243CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP2Cleared 510(K)
- K912343DISTENDABLE PALPATION PROBE2Cleared 510(K)
- K912023LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR2Cleared 510(K)
- K911817ENDOSCOPIC CLIP APPLIER2Cleared 510(K)
- K911488LAPAROSCOPIC RINSING CONTAINER2Cleared 510(K)
- K911053CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT2Cleared 510(K)
- K911478LAPAROSCOPIC SNARE POUCH2Cleared 510(K)
- K910246CORE DISPOSABLE SUCTION/IRRIGATION TUBING2Cleared 510(K)
- K911486LAPAROSCOPIC SUCTION/IRRIGATION CANNULA2Cleared 510(K)
- K911493LAPAROSCOPIC IRRIGATION PUMP2Cleared 510(K)
- K911157APPLICATOR LOOP SUTURES2Cleared 510(K)
- K911484LAPAROSCOPIC SUCTION IRRIGATION TUBING SET2Cleared 510(K)
- K910132STRYKER LAPAROSCOPE2Cleared 510(K)
- K894716DIRECTABLE COAXIAL CATHETER SET2Cleared 510(K)
- K862611STERILE DISPOSABLE TROCAR-SLEEVE DEVICES2Cleared 510(K)
- K833189HYDROFLOW SUCTION IRRIGATION SYSTEM2Cleared 510(K)
- K830719UNIVERSAL CANNULA2Cleared 510(K)
- K823581ELPHA 5002Cleared 510(K)
- K770712TROCAR SLEEVE SYSTEM 4MM TO 3.4MM2Cleared 510(K)
- K770711TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM2Cleared 510(K)
- K770348TROCAR SLEEVE SYSTEM, EXTENDED2Cleared 510(K)
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- NEQDevice, Telemedicine, Robotic2Product Code
- PDTBurn Resuscitation Decision Support Software2Product Code
- FDPApparatus, Pneumoperitoneum, Automatic2Product Code
- GCGPeritoneoscope2Product Code
- GCHMediastinoscope, Diagnostic2Product Code
- OTJLaparoscopic Single Port Access Device2Product Code
- OWNConfocal Optical Imaging2Product Code
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- POYPost Breast Biopsy Hemostatic Breast Compression Device2Product Code
- FXESpeculum, Non-Illuminated1Product Code
- FXFSpeculum, Illuminated1Product Code
- FXGSpecula Accessories1Product Code
- JYKHolder, Ear Speculum1Product Code
- KAGHolder, Speculum, Ent1Product Code
- QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2Product Code
- QZBSoftware Controlled Endoscope And Instrument Holder2Product Code
- SFEEndoscopic Video Imaging System / Software Component For Real Time Video Augmentation2Product Code
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SoftFix Balloon Trocar
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K211577
- 510(k) Type
- Traditional
- Applicant
- Unimax Medical Systems, Inc.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/5/2021
- Days to Decision
- 168 days
- Submission Type
- Summary