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
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HRXArthroscope2Product Code
- K243602Arthrex Spine Endoscope2Cleared 510(K)
- K242417VECTR – Video Endoscopic Carpal Tunnel Release System2Cleared 510(K)
- K243020MIDASVu2Cleared 510(K)
- K233800Vertos mild Device Kit (MDK-0002)2Cleared 510(K)
- K240535Digital ClarusScope System; Digital NeuroPEN System2Cleared 510(K)
- K233675FMS VUE™ Fluid Management and Tissue Debridement System2Cleared 510(K)
- K233115Hawkeye Control Unit with Eyas Endoscope2Cleared 510(K)
- K223709Kyphoplasty Balloon Catheter2Cleared 510(K)
- K221142Kyphoplasty Balloon System2Cleared 510(K)
- K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets2Cleared 510(K)
- K223406SmartRelease Endoscopic Soft Tissue Release System2Cleared 510(K)
- K223244Pristine Arthroscopic Visualization System2Cleared 510(K)
- K222490HBL Blade Assembly2Cleared 510(K)
- K213978TELIGEN System2Cleared 510(K)
- K212636CORUS Spinal System-X2Cleared 510(K)
- K212556mi-eye 3 needlescope with cannula, mi-tablet 32Cleared 510(K)
- K211297SMARTRELEASE Endoscopic Soft Tissue Release System2Cleared 510(K)
- K203480DOUBLEFLO system2Cleared 510(K)
- K202027Balex bone Expander System2Cleared 510(K)
- K193608EBERLE Shaver System C3 and Accessories2Cleared 510(K)
- K203526C Scope Visualization System2Cleared 510(K)
- K201113Resascope RS-01/B2Cleared 510(K)
- K202659Stryker Arthroscope2Cleared 510(K)
- K192921Zeos Aqua Vision Pump and tube2Cleared 510(K)
- K200067MectaScope System2Cleared 510(K)
- K200763Osteo-site Vertebral Balloon2Cleared 510(K)
- K201349Smith+Nephew Arthroscopes2Cleared 510(K)
- K200729HydroCision SpineJet System2Cleared 510(K)
- K191596Arcadia Balloon Catheter2Cleared 510(K)
- K192155Smith & Nephew DYONICS 25 Fluid Management System2Cleared 510(K)
- K191345Pegasus System2Cleared 510(K)
- K191259Stryker CrossFlow Integrated Arthroscopy Pump2Cleared 510(K)
- K191594Nuvis Battery Arthroscope2Cleared 510(K)
- K191579Voyant System2Cleared 510(K)
- K190804HydroCision TenJet Device2Cleared 510(K)
- K182287MEDINAUT Plus2Cleared 510(K)
- K190598CROSSWAY Spinal Access System2Cleared 510(K)
- K190201CORUS Spinal System2Cleared 510(K)
- K183165Pristine Scope2Cleared 510(K)
- K183470Precision Ideal Eyes Arthroscopes2Cleared 510(K)
- K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)2Cleared 510(K)
- K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control2Cleared 510(K)
- K181819SMARTRELEASE Endoscopic Soft Tissue Release System2Cleared 510(K)
- K181885Voyant System2Cleared 510(K)
- K181982MIDAScope and Introducer Kit, and MIDASystem2Cleared 510(K)
- K180766Endiscope, Endiscope Cervical2Cleared 510(K)
- K170703Single Use Arthroscopic Electrode (with Pencil)2Cleared 510(K)
- K180876DTRAX Spinal System2Cleared 510(K)
- K173311ARTHRO-Pump PA3042Cleared 510(K)
- K180315DISKOM2Cleared 510(K)
- K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)2Cleared 510(K)
- K171237FMS VUE II Fluid Management and Tissue Debridement System2Cleared 510(K)
- K172092Reprocessed Shavers/Burs2Cleared 510(K)
- K171794Smith & Nephew 25 Fluid Management System2Cleared 510(K)
- K162070JOINIX CANNULAR SYSTEM2Cleared 510(K)
- K163037Intra medullary endo-transilluminating device (iMET device)2Cleared 510(K)
- K162062AVAmax Vertebral Balloon, AVAflex Vertebral Balloon2Cleared 510(K)
- K161878PORTAGE System2Cleared 510(K)
- K162475mi-eye 2, mi-eye 2 monitor2Cleared 510(K)
- K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula2Cleared 510(K)
- K160249ULTRA Telescopes2Cleared 510(K)
- K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing2Cleared 510(K)
- K151268SPINAUT-V, SPINAUT-S, SPINAUT-I2Cleared 510(K)
- K153548VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM2Cleared 510(K)
- K151125AVAflex Vertebral Balloon System2Cleared 510(K)
- K150523AVAmax Vertebral Balloon2Cleared 510(K)
- K151532KYPHON ELEMENT Inflatable Bone Tamp2Cleared 510(K)
- K143705NeedleCam HD Visualization System2Cleared 510(K)
- K141557HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR2Cleared 510(K)
- K141326NEEDLE VIEW CH SCOPE KITS2Cleared 510(K)
- K141119CAMERA ENABLED PROBE2Cleared 510(K)
- K140903NUVIS ARTHROSCOPE2Cleared 510(K)
- K141002VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM2Cleared 510(K)
- K133682SCHOELLY ARTHROSCOPE2Cleared 510(K)
- K133941MITEK ARTHROSCOPES2Cleared 510(K)
- K130778DISCOSCOPES, CERVICAL ENDOSCOPES2Cleared 510(K)
- K133018OSI Q SYSTEM ARTHROSCOPES2Cleared 510(K)
- K133061ESPIN SYSTEM2Cleared 510(K)
- K132883HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)2Cleared 510(K)
- K131820AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G2Cleared 510(K)
- K131824AVAFLEX VERTEBRAL BALLOON SYSTEM2Cleared 510(K)
- K1311914MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS2Cleared 510(K)
- K130912OMNICUT RESECTION BLADE2Cleared 510(K)
- K130430IVAS 10MM AND 15MM BALLOON CATHETER2Cleared 510(K)
- K130169FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE2Cleared 510(K)
- K122411J-SCOPE SYSTEM2Cleared 510(K)
- K130057ESPIN2Cleared 510(K)
- K123441STRYKER CROSSFLOW ARTHROSCOPY PUMP2Cleared 510(K)
- K121261ASAP MUITISCOPE2Cleared 510(K)
- K122134FLEXLITE CAMERA2Cleared 510(K)
- K123771KYPHON EXPRESS II INFLATABLE BONE TAMPS2Cleared 510(K)
- K122861XTOOL2Cleared 510(K)
- K122662VERTIFLEX DIRECT DECOMPRESSION SYSTEM2Cleared 510(K)
- K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY2Cleared 510(K)
- K121548SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)2Cleared 510(K)
- K112548ALTOMEC ARTHROSCOPE2Cleared 510(K)
- K120553ESPIN2Cleared 510(K)
- K120680ENSPIRE DISCECTOMY SYSTEM2Cleared 510(K)
- K113352TRANSCORP SPINAL ACCESS SYSTEM2Cleared 510(K)
- K113362SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)2Cleared 510(K)
- K113028MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS2Cleared 510(K)
- K110992ENSPIRE DEBRIDER SYSTEM2Cleared 510(K)
- K103231KYPHON INFLATION SYRINGE2Cleared 510(K)
- K093471KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP2Cleared 510(K)
- K101864KYPHON XPANDER II INFLATABLE BONE TAMP2Cleared 510(K)
- K092723AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM2Cleared 510(K)
- K092977EBERLE SHAVER SYSTEM ACCESSORIES2Cleared 510(K)
- K101734VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES2Cleared 510(K)
- K093677STRYKER ARTHROSCOPE2Cleared 510(K)
- K093717C-MOR VISUALIZATION DEVICE2Cleared 510(K)
- K093409POWERPUMP ARTHROSCOPY SYSTEM2Cleared 510(K)
- K093062VERTOS MEDICAL MILD DEVICE KIT2Cleared 510(K)
- K092877INDISCAL ASPIRATION DEVICE AND ACCESSORIES2Cleared 510(K)
- K083552MAXMORESPINE TOM STICK2Cleared 510(K)
- K082841SPINAL FORAMINOSCOPE2Cleared 510(K)
- K091398ARTHROSCOPE2Cleared 510(K)
- K083707ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE2Cleared 510(K)
- K090132MAXMORESPINE SPINAL SYSTEM2Cleared 510(K)
- K090815PERCUTANEOUS DISCECTOMY SYSTEM2Cleared 510(K)
- K090303XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 90042Cleared 510(K)
- K090278ENSPIRE DEBRIDER SYSTEM2Cleared 510(K)
- K083161ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)2Cleared 510(K)
- K081240TIGER DISCECTOMY DEVICE2Cleared 510(K)
- K082355VISIONSENSE STEREOSCOPIC VISION SYSTEM2Cleared 510(K)
- K082293SURGVIEW INTEGRATED VISUALIZATION SYSTEM2Cleared 510(K)
- K082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-0000022Cleared 510(K)
- K081051SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE2Cleared 510(K)
- K080122SOPRO 670 ARTHROSCOPIC PUMP2Cleared 510(K)
- K080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES2Cleared 510(K)
- K072198X-VOID, SPIDER2Cleared 510(K)
- K080560HENKE SASS WOLF OF AMERICA ARTHROSCOPE2Cleared 510(K)
- K072879INNERVUE DIAGNOSTIC SCOPE SYSTEM2Cleared 510(K)
- K070021ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.02Cleared 510(K)
- K070874ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR2Cleared 510(K)
- K072706MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL2Cleared 510(K)
- K072675SMITH & NEPHEW ARTHROSCOPE2Cleared 510(K)
- K070233CONMED LINVATEC SMART GUARD IRRIGATOR2Cleared 510(K)
- K063326CONMED LINVATEC 24K IRRIGATION SYSTEM2Cleared 510(K)
- K062849SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM2Cleared 510(K)
- K062038X-STEN MILD TOOL KIT, MODEL MTK-00012Cleared 510(K)
- K062380FLOSIMPLE ARTHROSCOPY PUMP A1202Cleared 510(K)
- K061134EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES2Cleared 510(K)
- K061246ENDOSCOPIC SPINE SYSTEM2Cleared 510(K)
- K061345MODIFICATION TO ENDIUS ATAVI SYSTEM2Cleared 510(K)
- K060172REMA SHAVER BLADES2Cleared 510(K)
- K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW2Cleared 510(K)
- K053567ATHROCARE TOPAZ ARTHROWANDS2Cleared 510(K)
- K052241DISC-FX SYSTEM2Cleared 510(K)
- K053267ENDIUS ATAVI SYSTEM2Cleared 510(K)
- K051656OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM2Cleared 510(K)
- K051827JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE2Cleared 510(K)
- K051326SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K050580SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS2Cleared 510(K)
- K043568EQUESTRA FLUID DELIVERY SYSTEM2Cleared 510(K)
- K043395SMITH & NEPHEW VIDEOARTHROSCOPE2Cleared 510(K)
- K041824X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM2Cleared 510(K)
- K041233ARTHROJET XT2Cleared 510(K)
- K040483EQUESTRA FLUID DELIVERY SYSTEM2Cleared 510(K)
- K041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A2Cleared 510(K)
- K040612SKY BONE EXPANDER SYSTEM (SKY SYSTEM)2Cleared 510(K)
- K040919NUCLEOTOME PROBE SET, MODEL 212002Cleared 510(K)
- K040939SKY BONE EXPANDER SYSTEM (SKY SYSTEM)2Cleared 510(K)
- K041135VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES2Cleared 510(K)
- K033573LINVATEC 10K IRRIGATION SYSTEM2Cleared 510(K)
- K034037SKY BONE EXPANDER SYSTEM2Cleared 510(K)
- K033927ARTHOSCOPY PUMP A1152Cleared 510(K)
- K032891TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT2Cleared 510(K)
- K032358B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)2Cleared 510(K)
- K032473DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE2Cleared 510(K)
- K030082POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.8512Cleared 510(K)
- K032832IRRIGATION SETS2Cleared 510(K)
- K032529HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 513102Cleared 510(K)
- K032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A2Cleared 510(K)
- K031972ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,2Cleared 510(K)
- K031605INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY2Cleared 510(K)
- K031406EXOJET TISSUE MANAGEMENT SYSTEM2Cleared 510(K)
- K030402ARTHROSCOPY PUMP, MODEL A1072Cleared 510(K)
- K030009KSEA POWERSHAVER SYSTEM S22Cleared 510(K)
- K024291ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-64752Cleared 510(K)
- K030096VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW2Cleared 510(K)
- K030196DYONICS POWER CONTROL UNIT2Cleared 510(K)
- K030307DAVOL ARTHROVENT OUTFLOW TUBING2Cleared 510(K)
- K023783SOHNIKS2Cleared 510(K)
- K023777ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 1832Cleared 510(K)
- K023187KSEA SPINOSCOPE2Cleared 510(K)
- K022199ENDIUS ATAVI SYSTEM2Cleared 510(K)
- K020457AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE2Cleared 510(K)
- K022578ENDIUS FLEXTIP BLADE2Cleared 510(K)
- K021748ENDIUS ATAVI SYSTEM2Cleared 510(K)
- K012667REPROCESSED ARTHROSCOPIC SHAPERS2Cleared 510(K)
- K020761POWER TEK II2Cleared 510(K)
- K020688HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR2Cleared 510(K)
- K012640ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS2Cleared 510(K)
- K020083TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.6012Cleared 510(K)
- K013513DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE2Cleared 510(K)
- K011202MSI BIPOLAR SHEATH2Cleared 510(K)
- K011454SPINE SCOPE, MODEL 21802Cleared 510(K)
- K013117RESECTION ABLATOR2Cleared 510(K)
- K012630REPROCESSED LINVATEC ARTHROSCOPIC BURS2Cleared 510(K)
- K012624REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS2Cleared 510(K)
- K012652REPROCESSED DYONICS ARTHROSCOPIC BURS2Cleared 510(K)
- K012611REPROCESSED DYONICS ARTHROSCOPIC SHAVERS2Cleared 510(K)
- K012635REPROCESSED STRYKER ARTHROSCOPIC SHAVERS2Cleared 510(K)
- K012613REPROCSSED LINVATEC SHAVERS2Cleared 510(K)
- K012605REPROCESSED ATHROSCOPICS BURS2Cleared 510(K)
- K012536REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES2Cleared 510(K)
- K012346VANGUARD REPROCESSED ARTHROSCOPIC BLADES2Cleared 510(K)
- K003198VULCAN TAC PROBES, MODEL 911XXX2Cleared 510(K)
- K010345KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS2Cleared 510(K)
- K003831ARTHROSCOPES2Cleared 510(K)
- K011083ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND2Cleared 510(K)
- K010987KSEA MINIATURE TELESCOPE AND ACCESSORIES2Cleared 510(K)
- K010811PERC-D SPINEWAND2Cleared 510(K)
- K010677XPS 3000 SYSTEM2Cleared 510(K)
- K003740MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION2Cleared 510(K)
- K002088SHAVER ABLATOR2Cleared 510(K)
- K003893VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X2Cleared 510(K)
- K003572DYONICS CONTROL RF SYSTEM2Cleared 510(K)
- K010246KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A2Cleared 510(K)
- K003695MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES2Cleared 510(K)
- K010179EBI VUECATH SPINAL ENDOSCOPIC SYSTEM2Cleared 510(K)
- K003898EBI VUECATH SPINAL ENDOSCOPIC SYSTEM2Cleared 510(K)
- K002931METRX SYSTEM2Cleared 510(K)
- K002764HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR2Cleared 510(K)
- K001741RADIONICS RF DISC CATHETER ELECTRODE SYSTEM2Cleared 510(K)
- K002437ENDIUS ENDOSCOPIC ACCESS SYSTEM2Cleared 510(K)
- K001918KSEA PERCUTANEOUS FORAMINOSCOPY SET2Cleared 510(K)
- K002040FMS SOLO2Cleared 510(K)
- K002402VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM2Cleared 510(K)
- K002008SURGICAL DYNAMICS SPINAL RETRACTOR2Cleared 510(K)
- K001226SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM2Cleared 510(K)
- K000691VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS2Cleared 510(K)
- K000198CORTEK ARTHROSCOPE2Cleared 510(K)
- K000046KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)2Cleared 510(K)
- K994363INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)2Cleared 510(K)
- K994425MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM2Cleared 510(K)
- K000153ARTHRO-SURGIMAT-A1032Cleared 510(K)
- K991656AED ARTHROSCOPE2Cleared 510(K)
- K993540ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE2Cleared 510(K)
- K993021METRX SYSTEM2Cleared 510(K)
- K992621ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES2Cleared 510(K)
- K992583MASS (MICRO-ACCESS SPINE SYSTEM)2Cleared 510(K)
- K993009HYDROCISION ARTHROJET SYSTEM WITH CAUTERY2Cleared 510(K)
- K990397FLEXIBLE FIBERSCOPES & ACCESSORIES2Cleared 510(K)
- K992782NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES2Cleared 510(K)
- K990324NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM2Cleared 510(K)
- K992876VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM2Cleared 510(K)
- K992474ARTHROSCOPE / MEDIFIX INC.2Cleared 510(K)
- K991794ENDOSCOPIC SPINAL ACCESS SYSTEM2Cleared 510(K)
- K984304RIWO DRIVE GENERATOR2Cleared 510(K)
- K992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES2Cleared 510(K)
- K990524E9000 SYSTEM2Cleared 510(K)
- K990911MTP ARTHROPUMP DISPOSABLE TUBING SET2Cleared 510(K)
- K991051KSEA EPIDUROSCOPE2Cleared 510(K)
- K990459EBI VUECATH ENDOSCOPIC SYSTEN2Cleared 510(K)
- K983652ABLATOR ELECTRODE2Cleared 510(K)
- K990443ARTHRO-SURGIMAT-2000 ECU2Cleared 510(K)
- K983144FLEXPOSURE RETRACTOR2Cleared 510(K)
- K983142KSEA C-MOUNT ARTHROSCOPES2Cleared 510(K)
- K983910ARTHRO-SURGIMAT-15002Cleared 510(K)
- K983384DCI ENDOSCOPE2Cleared 510(K)
- K983025XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT2Cleared 510(K)
- K982133OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT2Cleared 510(K)
- K982484EBI VUECATH ENDOSCOPIC SPINAL SYSTEM2Cleared 510(K)
- K982375STRYKER HIP ARTHOROSCOPY SET2Cleared 510(K)
- K982266HYDROCISION ARTHROJET SYSTEM2Cleared 510(K)
- K981636INTEGRATED DRIVE/PUMP SYSTEM2Cleared 510(K)
- K980734MYELOTEC VIDEO GUIDED CATHETER2Cleared 510(K)
- K981251KYPHON INFLATABLE BONE TAMP2Cleared 510(K)
- K981269UNIVERSAL DRIVE SYSTEM2Cleared 510(K)
- K981156DYONICS INTELIJET INFLOW/OUTFLOW CANNULA2Cleared 510(K)
- K973405YEUNG ENDOSCOPIC SPINE SYSTEM2Cleared 510(K)
- K974579PERCSCOPE MODEL 26002Cleared 510(K)
- K973499XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM2Cleared 510(K)
- K971781GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES2Cleared 510(K)
- K971649KSEA ARTHROPUMP PLUS2Cleared 510(K)
- K973195TOTAL PERFORMANCE SYSTEM SHAVER2Cleared 510(K)
- K972768BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM2Cleared 510(K)
- K970511DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES2Cleared 510(K)
- K971996MEDIVISION ARTHROSCOP2Cleared 510(K)
- K971676LIMITED REUSE ENDOSCOPIC BLADES2Cleared 510(K)
- K971083ARTHROSCOPE2Cleared 510(K)
- K971059UNIVERSAL DRIVE SYSTEM2Cleared 510(K)
- K971253VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS2Cleared 510(K)
- K970642TENOSCOPE2Cleared 510(K)
- K970562TENOSNARE2Cleared 510(K)
- K970055KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY2Cleared 510(K)
- K964879PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM2Cleared 510(K)
- K964975COHORT DISCECTOMY SYSTEMS (CDS)2Cleared 510(K)
- K964919EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM2Cleared 510(K)
- K963304STRYKER TEMPEST ORTHOPEDIC PUMP2Cleared 510(K)
- K962075HSW GMBH ARTHROSCOPE2Cleared 510(K)
- K964215ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM2Cleared 510(K)
- K963029KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE2Cleared 510(K)
- K963524KSEA LARGE JOINT ARTHROSCOPY SET2Cleared 510(K)
- K963332THERMO-PLASTIC SHAVER BLADES2Cleared 510(K)
- K961228KARL STORZ MAGNIFYING ARTHROSOCPES2Cleared 510(K)
- K961590APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET2Cleared 510(K)
- K962330AMO ARTHOSCOPES2Cleared 510(K)
- K960194MYELOTEC MYELOSCOPE2Cleared 510(K)
- K962114ARTHRO-SURGIMAT2Cleared 510(K)
- K962321ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 9702Cleared 510(K)
- K961747ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)2Cleared 510(K)
- K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER2Cleared 510(K)
- K961713INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY2Cleared 510(K)
- K961244KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME2Cleared 510(K)
- K960805ARTHOSCOPE2Cleared 510(K)
- K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE2Cleared 510(K)
- K960222PERCUTANEOUS ENDOSCOPIC DISCECTOMY2Cleared 510(K)
- K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS2Cleared 510(K)
- K955480BOZOTTA REINSERTION FORCEPS2Cleared 510(K)
- K955914LIMITED REUSE ARTHROSCOPIC BLADES2Cleared 510(K)
- K955500FMS ARTHOPROBE2Cleared 510(K)
- K954016VIDEOSCOPE W/IRRIGATION SHEATH2Cleared 510(K)
- K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES2Cleared 510(K)
- K955652KARL STORZ TARGETING UNIT2Cleared 510(K)
- K954964AQUACENTER 2000 SYSTEM2Cleared 510(K)
- K955471INCL ENDOSCOPE2Cleared 510(K)
- K954627ECTRA II LIGAMENT RELEASE SYSTEM2Cleared 510(K)
- K955273CANNULOC THREADED CANNULA2Cleared 510(K)
- K955272TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY2Cleared 510(K)
- K955037RIGID NEUROVIEW ENDOSCOPE2Cleared 510(K)
- K954981KARL STORZ HEMPFLING DILATION SET2Cleared 510(K)
- K953998DISCETOME TISSUE ASPIRATOR2Cleared 510(K)
- K946087INCLUSICE II(TM) ENDOSCOPE2Cleared 510(K)
- K954882RIZA-RIBE NEEDLE (MODIFICATION)2Cleared 510(K)
- K954510RRIANGLE KNIFE2Cleared 510(K)
- K954509PROBE KNIFE2Cleared 510(K)
- K954508RETRACTOR2Cleared 510(K)
- K954507RETROGRADE KNIFE2Cleared 510(K)
- K954465FMS DUO2Cleared 510(K)
- K942029ARTHROSCOPE2Cleared 510(K)
- K954052ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES2Cleared 510(K)
- K954014PERCUTANEOUS DISCECTOMY CANNULA SYSTEM2Cleared 510(K)
- K954440APEX TUBING SET2Cleared 510(K)
- K954476PROBE2Cleared 510(K)
- K954475BLUNT DISSECTOR, CURVED2Cleared 510(K)
- K954459CONICAL OBTURATOR2Cleared 510(K)
- K954463DISSECTING OBTURATOR2Cleared 510(K)
- K954458BOAT NOSE OBTURATOR2Cleared 510(K)
- K954464CARPAL TUNNEL SLOTTED CANNULA2Cleared 510(K)
- K954217ARTHROPLAST & ARTHRO-CUTTER2Cleared 510(K)
- K954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET2Cleared 510(K)
- K953868GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH2Cleared 510(K)
- K953659ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION)2Cleared 510(K)
- K930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY2Cleared 510(K)
- K953695DYONICS DISPOSABLE ARTHROSCOPIC BLADES2Cleared 510(K)
- K946174BLOCK(TM) ARTHROSCOPIC TOOL KIT2Cleared 510(K)
- K952639DISPOSABLE TOOTHED GRASPING FORCEP2Cleared 510(K)
- K952630DISPOSABLE BIOPSY FORCEP2Cleared 510(K)
- K944553PRESSURE SENSING SCOPE SHEATH SYSTEM2Cleared 510(K)
- K953484POLLUX OA/POLLUX 30A/POLLUX 70A2Cleared 510(K)
- K953075UNIMAT PUMP2Cleared 510(K)
- K951267STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM2Cleared 510(K)
- K944593STRYKER PRESSURE SENSING CANNULA2Cleared 510(K)
- K930084MICRO-ARTHROSCOPE2Cleared 510(K)
- K953550CO2 ARTHROFLATOR2Cleared 510(K)
- K950093AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES2Cleared 510(K)
- K941862INTEQ TFCC REPAIR SYSTEM2Cleared 510(K)
- K953387ECTRA LIGAMENT RELEASE SYSTEM2Cleared 510(K)
- K951268SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM2Cleared 510(K)
- K951624ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM2Cleared 510(K)
- K951941CITATION MULTIPLE USE DELTA SCOPE2Cleared 510(K)
- K951843REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT2Cleared 510(K)
- K950054ENDO-BEND(TM) SHAVER2Cleared 510(K)
- K945390CITATION DELTA SCOPE2Cleared 510(K)
- K946290CITATION POWER TOOL2Cleared 510(K)
- K951354OLYMPUS ARTHROSCOPY SYSTEM2Cleared 510(K)
- K945684POC ARTHROSCOPE AND ACCESSORIES2Cleared 510(K)
- K945787KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES2Cleared 510(K)
- K944500ACUFEX PATELLAR BONE BLOCK SIZER2Cleared 510(K)
- K951859ACUFEX ENDOBUTTON PACK2Cleared 510(K)
- K945891KARL STORZ KNIVES, CURETTS, HOOKS, PROBES2Cleared 510(K)
- K952192KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES2Cleared 510(K)
- K951026DAVOL ARTHRO-FLO 32Cleared 510(K)
- K951163GORE SMOOTHER GUIDED RASP2Cleared 510(K)
- K950592ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES2Cleared 510(K)
- K943052ARTHROSCOPIC TELESCOPES2Cleared 510(K)
- K945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES2Cleared 510(K)
- K940179ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.0112Cleared 510(K)
- K950242ARGUS ARTHROSCOPY INSTRUMENT SYSTEM2Cleared 510(K)
- K950561KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP2Cleared 510(K)
- K950501DANEK RIGID ARTHROSCOPE2Cleared 510(K)
- K943356INCLUSIVE ENDOSCOPE2Cleared 510(K)
- K9507051.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE2Cleared 510(K)
- K946151BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS2Cleared 510(K)
- K9404832.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE2Cleared 510(K)
- K950130MICRO-ENDO(TM) INSTRUMENTS2Cleared 510(K)
- K941188CLARUS NEURO ENDOSCOPE (MODEL 2230)2Cleared 510(K)
- K940144CLARUS PHOENIX ENDOSCOPE2Cleared 510(K)
- K941709ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS2Cleared 510(K)
- K945973FMS ARTHROSCOPY CANNULA2Cleared 510(K)
- K946313TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER2Cleared 510(K)
- K943450ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 9702Cleared 510(K)
- K943937MANUAL INSTRUMENTS2Cleared 510(K)
- K944210ARTHROSCOPE ACCESSORIES2Cleared 510(K)
- K943426ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE2Cleared 510(K)
- K944842ARTHROSCOPE2Cleared 510(K)
- K941651CTS RELIEF KIT2Cleared 510(K)
- K942298THE KARL STORZ ARTHROPUMP2Cleared 510(K)
- K943943TRANSTIBIAL ACL DISPOSABLES KIT2Cleared 510(K)
- K940230ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS2Cleared 510(K)
- K943154KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS2Cleared 510(K)
- K943323STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K943628ARTHROSCOPE2Cleared 510(K)
- K940287MENISCAL SUTURE INSTRUMENTARIUM2Cleared 510(K)
- K943676DANEKSCOPE OPTI-PROBE2Cleared 510(K)
- K943666ENVISION ARTHROSCOPY VISUALIZATION SYSTEM2Cleared 510(K)
- K942427ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE2Cleared 510(K)
- K941333SE5 ARTHROSCOPY SYTEM2Cleared 510(K)
- K942081ENVISION ARTHROSCOPY SYSTEM2Cleared 510(K)
- K943985LIMITED REUSE BLADES2Cleared 510(K)
- K940847ENDOSCOPIC PLANTAR FASCIA KIT2Cleared 510(K)
- K9417183M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD2Cleared 510(K)
- K9413883M FLUID IRRIGATION SYSTEM2Cleared 510(K)
- K934707GALILEO ARTHROSCOPES2Cleared 510(K)
- K940913SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM2Cleared 510(K)
- K9421014-LEAD IRRIGATION SET2Cleared 510(K)
- K942846ACUFEX(R) ENDO-FEMORAL AIMER2Cleared 510(K)
- K942834ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA2Cleared 510(K)
- K942079MANUAL SURGICAL INSTRUMENTS2Cleared 510(K)
- K941964LMT ARTHROSCOPIC SUTURING INSTRUMENTS2Cleared 510(K)
- K941036CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES2Cleared 510(K)
- K940290ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS2Cleared 510(K)
- K941273INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER2Cleared 510(K)
- K935617ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION2Cleared 510(K)
- K941691REVO ROTATOR CUFF REPAIR SYSTEM2Cleared 510(K)
- K940234CARPAL TUNNEL SYSTEM2Cleared 510(K)
- K936280GALILEO ARTHROSCOPES2Cleared 510(K)
- K940554TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS2Cleared 510(K)
- K940222SMITH AND NEPHEW SPINE DEFLECTING FORCEPS2Cleared 510(K)
- K932099ACUMED FLEXIBLE CANNULA2Cleared 510(K)
- K932090ACUFEX DISPOSABLE MENISCAL CANNULA2Cleared 510(K)
- K940090ARTHROSCOPE2Cleared 510(K)
- K940515POLY BLADES2Cleared 510(K)
- K941269GORE SMOOTHER II AND GORE BPTB2Cleared 510(K)
- K936213ARTHROSCOPES AND ACCESSORIES2Cleared 510(K)
- K941364ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS2Cleared 510(K)
- K940981ACUFEX LINEAR/ROTARY INSTRUMENTS2Cleared 510(K)
- K940985ACUFEX(R) ARTHROPLASTY INSTRUMENTS2Cleared 510(K)
- K940481ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM2Cleared 510(K)
- K935221STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS2Cleared 510(K)
- K931323MOUNTABLE KNIFE2Cleared 510(K)
- K940623ACUFEX SURETAC IXC SYSTEMS2Cleared 510(K)
- K940506ACUFEX ARTHROSCOPIC SUTURE CUTTER2Cleared 510(K)
- K933576ARTHROSCOPE, DISPOSABLE2Cleared 510(K)
- K940075SHAVER BLADE SET2Cleared 510(K)
- K934379LINVATEC POWERLINK SURGICAL SHAVING SYSTEM2Cleared 510(K)
- K921119ARTHREX ARTHROSCOPE2Cleared 510(K)
- K931076ARTHOSCOPE AND ACCESSORIES2Cleared 510(K)
- K931109NUCLEOTOME E KIT2Cleared 510(K)
- K922519MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY2Cleared 510(K)
- K940454GRASPING FORCEPS, PUNCHES, SCISSORS2Cleared 510(K)
- K934720AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE2Cleared 510(K)
- K934332SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES2Cleared 510(K)
- K933470ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM2Cleared 510(K)
- K932869ARTHROPLANE2Cleared 510(K)
- K934401ARTHROTEK CANNULA SYSTEM2Cleared 510(K)
- K933638ACUMED CARPAL TUNNEL RELEASE KIT2Cleared 510(K)
- K933070ARTHTOTEK PRECISION HAND INSTRUMENTATION2Cleared 510(K)
- K936206GORE SMOOTHER CRUCIAL TOOL2Cleared 510(K)
- K934181ACUFEX ADJUSTABLE-LENGTH CANNULA2Cleared 510(K)
- K932460ACUFEX MENISCAL RASPS2Cleared 510(K)
- K932718ACUFEX METAL ACL CANNULA2Cleared 510(K)
- K933949DISPOSABLE ARTHROSCOPIC ACCESSORY2Cleared 510(K)
- K930152ARTHREX TIBIAL TUNNEL CANNULA2Cleared 510(K)
- K925160ARTHRO FMS 42Cleared 510(K)
- K934299DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION2Cleared 510(K)
- K934270ACUFEX ARTHROSCOPE2Cleared 510(K)
- K926212ARTHREX INSTRUMENTS ( HIP )2Cleared 510(K)
- K926303ARTHREX INSTRUMENTS (WRIST)2Cleared 510(K)
- K931621ACUFEX PRO-PAC AND ISO-PAC2Cleared 510(K)
- K923514CLARUS SERIES 2100 ENDOSCOPE2Cleared 510(K)
- K924016SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.2Cleared 510(K)
- K922486DANEK TISSUE CUTTING AND REMOVAL SYSTEM2Cleared 510(K)
- K922321OMNI ARTHROSCOPE2Cleared 510(K)
- K925226SIGHT-PLUS ARTHROSCOPE2Cleared 510(K)
- K921985ARTHROSCOPE & ACCESSORIES2Cleared 510(K)
- K923069RESTORE TUNNEL PLUG2Cleared 510(K)
- K924773BURTON H- BASE TABLE - MODEL 19902Cleared 510(K)
- K924494CITSCOPE, BENDABLE -- MODIFICATION2Cleared 510(K)
- K925573ACUFEX T-BAR2Cleared 510(K)
- K925083ENDOTRAK SYSTEM2Cleared 510(K)
- K925577DANEK TISSUE RESECTING SYSTEM2Cleared 510(K)
- K924144ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)2Cleared 510(K)
- K911729DANEKSCOPE AND ACCESSORIES2Cleared 510(K)
- K926193ARTHREX INSTRUMENTS (SHOULDER GP. 1)2Cleared 510(K)
- K926111ARTHROSCOPIC KNEE INSTRUMENTS2Cleared 510(K)
- K926062ARTHROSCOPIC KNEE INSTRUMENTS2Cleared 510(K)
- K925996ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES2Cleared 510(K)
- K924017SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST.2Cleared 510(K)
- K925995ARTHREX INSTRUMENTS (KNEE, GP 3)2Cleared 510(K)
- K925986ARTHROSCOPIC ACL DRILL SYSTEM2Cleared 510(K)
- K925954ARTHREX INSTRUMENTS (BASIC)2Cleared 510(K)
- K925884ARTHROSCOPIC RETRACTORS AND GRASPERS2Cleared 510(K)
- K925814ARTHREX INSTRUMENTS (BASIC)2Cleared 510(K)
- K925458ARTHREX RING CURETTE2Cleared 510(K)
- K925457ARTHREX BAYONET KNIFE2Cleared 510(K)
- K925456ARTHROSCOPIC INSTRUMENTS2Cleared 510(K)
- K923525NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR2Cleared 510(K)
- K923142ARTHREX PLUS2Cleared 510(K)
- K925455ARTHREX ATRAUMATIC MINI-GRASPER2Cleared 510(K)
- K922890ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES2Cleared 510(K)
- K925437ACUFEX CANNULATED BONE TUNNEL PLUGS2Cleared 510(K)
- K921823ARTHREX ARTHROSCOPY ICE BLADE2Cleared 510(K)
- K922557ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT2Cleared 510(K)
- K920454CLEARTRAC CANNULA2Cleared 510(K)
- K922391ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS2Cleared 510(K)
- K922318DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET2Cleared 510(K)
- K922144CITSCOPE (MODEL EXTENSIONS)2Cleared 510(K)
- K921692INTEGRATED VIDEO SYSTEM2Cleared 510(K)
- K920800INTEGRATED ENDOSCOPY SYSTEM 10002Cleared 510(K)
- K914963SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET2Cleared 510(K)
- K915721MODEL AR-6300 INFUSION PUMP2Cleared 510(K)
- K913401SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL2Cleared 510(K)
- K914559SMALL JOINT SYSTEM2Cleared 510(K)
- K901692DANEK SPINALSCOPE2Cleared 510(K)
- K914282NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER2Cleared 510(K)
- K913145NUCLEOTOME TISSUE ASPIRATOR/CUTTER2Cleared 510(K)
- K9120993M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA2Cleared 510(K)
- K911974PGK STEREOTACTIC DEVICE2Cleared 510(K)
- K913028ARTHRO-FLOW IRRIGATION 2 SYSTEM2Cleared 510(K)
- K912957CONCEPT MICROMILL2Cleared 510(K)
- K911296OPTICAL CATHETER ARTHROSCOPE2Cleared 510(K)
- K913347PALMER ARCH SUPPRESSOR2Cleared 510(K)
- K912453INTELIJET TM FLUID MANAGEMENT SYSTEM2Cleared 510(K)
- K912205MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO2Cleared 510(K)
- K912206MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.2Cleared 510(K)
- K912871INSIDE JOB2Cleared 510(K)
- K912108BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS2Cleared 510(K)
- K911205ARTHROSCOPY INSTRUMENT CANNULA2Cleared 510(K)
- K910858STRYKER ARTHROSCOPIC INFUSION PUMP2Cleared 510(K)
- K910587MINISCOPE2Cleared 510(K)
- K910674FLEXMEDICS MALLEABLE CANNULA2Cleared 510(K)
- K911300MICROSURGICAL INSTRUMENTS2Cleared 510(K)
- K905014AMSET PLD SYSTEM2Cleared 510(K)
- K910164ORTHOCONCEPT ARTHROSCOPIC PUMP2Cleared 510(K)
- K905785ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)2Cleared 510(K)
- K904859MOTOR DRIVEN EXTIRPATION INSTRUMENTS2Cleared 510(K)
- K904465FLEXIBLE ARTHROSCOPE2Cleared 510(K)
- K904284ARTHROSCOPIC SURGICAL BLADE2Cleared 510(K)
- K904479SURGICAL INST.:1030,1010,1011,1012,1013,1014,10152Cleared 510(K)
- K902778SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER2Cleared 510(K)
- K904720POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES2Cleared 510(K)
- K900608SHEPPERD LUMBAR DISCECTOMY SYSTEM2Cleared 510(K)
- K900616SHEPPERD CUTTING FORCEPS2Cleared 510(K)
- K900615SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE2Cleared 510(K)
- K900614SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)2Cleared 510(K)
- K900613SHEPPERD SHELTER TUBE COMPLETE & DRILL2Cleared 510(K)
- K900612SHEPPERD TREPHINE SET (GS-501-30-V)2Cleared 510(K)
- K900611SHEPPERD DILATATION TUBE SET (GS-501-20-H)2Cleared 510(K)
- K900610SHEPPERD CANNULA STILLETTE & OBDURATOR SET2Cleared 510(K)
- K900609SHEPPERD STRAIGHT AND CURVED NEEDLES2Cleared 510(K)
- K903312CYGNASCOPE2Cleared 510(K)
- K903620MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM2Cleared 510(K)
- K901765POSTEROMEDIAL GUIDE2Cleared 510(K)
- K902168ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)2Cleared 510(K)
- K901735ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 34442Cleared 510(K)
- K901617ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)2Cleared 510(K)
- K900812MEDICAM ARTHROSCOPE SYSTEMS2Cleared 510(K)
- K901505ARTHROSCOPIC ELECTROSURGICAL PROBE2Cleared 510(K)
- K900680EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS2Cleared 510(K)
- K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM2Cleared 510(K)
- K896678SILICONE PLUG2Cleared 510(K)
- K896770ARTHRODISTRACTOR2Cleared 510(K)
- K896416DYONICS SHOULDER PORTAL SYSTEM2Cleared 510(K)
- K896584ARTHROSCOPIC TUBING SHEATH2Cleared 510(K)
- K893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY2Cleared 510(K)
- K896538DISPOSABLE 45 DEGREE SHAVER2Cleared 510(K)
- K896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR2Cleared 510(K)
- K894990DAVOL ARTHROSCOPY CANNULA2Cleared 510(K)
- K890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES2Cleared 510(K)
- K895685SMALL JOINT HAND INSTRUMENTS2Cleared 510(K)
- K894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE2Cleared 510(K)
- K894558MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET2Cleared 510(K)
- K892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)2Cleared 510(K)
- K894303MEDSCOPE 4MM ARTHROSCOPE2Cleared 510(K)
- K892062PS3500 ARTHROSCOPIC SURGICAL SYSTEM2Cleared 510(K)
- K884314LEONARD MEDICAL 1.7MM ARTHROSCOPE2Cleared 510(K)
- K884301EDWARDS DISPOSABLE ARTHROSCOPY CANNULA2Cleared 510(K)
- K885183ENDOSCOPIC LIGHT SOURCE2Cleared 510(K)
- K875130BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS2Cleared 510(K)
- K882469CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES2Cleared 510(K)
- K884302EDWARDS ARTHROSCOPIC LEG HOLDER2Cleared 510(K)
- K883300IRRIGATION SET2Cleared 510(K)
- K883361ARTHRO-TRAC(TM)2Cleared 510(K)
- K88171528200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES2Cleared 510(K)
- K8817033M CARPAL TUNNEL2Cleared 510(K)
- K881792CANNULA MODEL AR-65512Cleared 510(K)
- K880295CANNULA MODEL AR-60012Cleared 510(K)
- K880203HERMAN CANNULA SET2Cleared 510(K)
- K880414TENDON HARVESTER2Cleared 510(K)
- K874911MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG2Cleared 510(K)
- K880331HOOK PUNCH FORCEPS FOR ARTHROSCOPY2Cleared 510(K)
- K873331ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG2Cleared 510(K)
- K880205EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES2Cleared 510(K)
- K873619ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)2Cleared 510(K)
- K874515CONCEPT SUTURE NEEDLE2Cleared 510(K)
- K873650C-O-T SET (CANNULA, OBTURATOR AND TROCAR) #TM-13602Cleared 510(K)
- K872533THE CART2Cleared 510(K)
- K872986MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT2Cleared 510(K)
- K871181ARTHROCOMBI 50032Cleared 510(K)
- K871180ARTHRO AUTOMAT 50022Cleared 510(K)
- K873030CONCEPT ARTHROSCOPIC PORTAL ROD2Cleared 510(K)
- K872544IRRIGATION PRESSURE MONITOR2Cleared 510(K)
- K872270ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP2Cleared 510(K)
- K871621THE KARL STORZ MODEL 28805 ARTHRO PUMP2Cleared 510(K)
- K870654EFER ARTHROSCOPE2Cleared 510(K)
- K865066ARTHROFLATOR2Cleared 510(K)
- K870915SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM2Cleared 510(K)
- K864892ELLISON ARTHROSCOPY CHEATER2Cleared 510(K)
- K864476LEG HOLDER2Cleared 510(K)
- K862017ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT2Cleared 510(K)
- K864513LP ARTHROSCOPIC THIGH HOLDING DEVICE2Cleared 510(K)
- K864163HALL DUNBAR DRILL GUIDE SYSTEM2Cleared 510(K)
- K863986XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES2Cleared 510(K)
- K862990CANCELLOUS SCREW2Cleared 510(K)
- K862991LIGAMENT WASHER2Cleared 510(K)
- K863590UNIVERSAL CANNULA SYSTEM2Cleared 510(K)
- K863605ARTHROSCOPIC IRRIGATION PUMP2Cleared 510(K)
- K863597AMERICAN EDWARDS 4.0 MM ARTHROSCOPE2Cleared 510(K)
- K863396CONCEPT INTRAVISION ARTHROSCOPE SYSTEM2Cleared 510(K)
- K862778HALL CANNLULA SYSTEM2Cleared 510(K)
- K862275ARTHROSCOPE2Cleared 510(K)
- K862657CONCEPT CURETTE2Cleared 510(K)
- K862658CONCEPT ARTHROSCOPIC KNIFE2Cleared 510(K)
- K861859CABOT VIDEOSCOPE2Cleared 510(K)
- K861268ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH2Cleared 510(K)
- K860607MARKOPTIC IMPROVED ARTHROSCOPE2Cleared 510(K)
- K854889FLEX-I-GRASP2Cleared 510(K)
- K852759AMERICAN EDWARDS LABORATORIES FLEXISCOPE2Cleared 510(K)
- K852592CO2 FOR ARTHROSCOPY2Cleared 510(K)
- K851374AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE2Cleared 510(K)
- K851229CODMAN ARTHROSCOPE2Cleared 510(K)
- K841241ANTERIOR CRUCIATE LIGAMENT GRASPER2Cleared 510(K)
- K843604RICHARD ARTHROSCOPE2Cleared 510(K)
- K843208ACUFEX ARTHROSCOPE2Cleared 510(K)
- K841624PROBE2Cleared 510(K)
- K841607AMERICAN EDWARDS LABS FLEXISCOPE2Cleared 510(K)
- K842323AMER. EDWARDS LAB FLEXISCOPE OBTURATOR2Cleared 510(K)
- K841087FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-10002Cleared 510(K)
- K834146ANTHROSCOPY SYSTEM2Cleared 510(K)
- K834076ARTHROSCOPIC LEG HOLDER 434-212Cleared 510(K)
- K833727CABOT ARTHROSCOPY SYSTEM2Cleared 510(K)
- K833587DISPOSABLE ARTHROSCOPY BLADE2Cleared 510(K)
- K832315ARTHROSCOPY FLUID MGMT. SYSTEM2Cleared 510(K)
- K832341ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC2Cleared 510(K)
- K832277ACUFLEX LEVY ACL DRILL GUIDE SYS2Cleared 510(K)
- K831218ARTHROSCOPY INFUSION SYS..VALVE2Cleared 510(K)
- K831656ARTHROSCOPY KNIVES/PROBES/BENDING TOOL2Cleared 510(K)
- K831248PATELLAR FAT PAD RETRACTOR2Cleared 510(K)
- K830673CRAFON ARTHROSCOPY LINES2Cleared 510(K)
- K830499ESA ELECTROSURGICAL ARTHROSCOPY GENERA2Cleared 510(K)
- K830120IMPROVED ARTHROSCOPE2Cleared 510(K)
- K823848CRAFTON ARTHROSCOPY PUMP AP-102Cleared 510(K)
- K823832ESA ARTHROSCOPY CANNULA TRAY2Cleared 510(K)
- K823499INTRA-ARTICULAR C02 INSUFFLATOR2Cleared 510(K)
- K821847I.M. ARTHROSCOPE2Cleared 510(K)
- K821672PROFLEX2Cleared 510(K)
- K821694ARTHROLUX ARTHROSCOPE2Cleared 510(K)
- K821359ARTHROSCOPES & ASSOCIATED INSTRUMENTS2Cleared 510(K)
- K820777MINI-MICRO ARTHROSCOPIC SCAPEL2Cleared 510(K)
- K820776CANNUOATED TROCHAR2Cleared 510(K)
- K820275ARTHROSCOPIC HARPOON2Cleared 510(K)
- K820225MENISCUS EXTRACTOR2Cleared 510(K)
- K811861ARTHROSCOPIC LEG HOLDER2Cleared 510(K)
- K811675SURGICAL INSTRUMENTS FOR USE W/ZIMMER2Cleared 510(K)
- K811596ZIMMER ARTHROSCOPY SYSTEM2Cleared 510(K)
- K771200ORTHOSCOPE2Cleared 510(K)
- K770710NEEDLE, SPRAY2Cleared 510(K)
- LZEIsometer1Product Code
- NBHAccessories, Arthroscopic1Product Code
- NGRTester, Stiffness, Cartilage, Arthroscopic2Product Code
- PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures2Product Code
- QGQBone Indentation Device2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DOUBLEFLO system
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K203480
- 510(k) Type
- Traditional
- Applicant
- Hemodia SAS
- Country
- France
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/5/2021
- Days to Decision
- 129 days
- Submission Type
- Summary