Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- FCPBox, Battery, Pocket1Product Code
- FCQLight Source, Incandescent, Diagnostic2Product Code
- EXQCystometer, Electrical Recording2Product Code
- EXRUrinometer, Mechanical2Product Code
- EXSUrinometer, Electrical2Product Code
- EXWPill, Radio2Product Code
- EXYUroflowmeter2Product Code
- EXZEquipment, Photographic, For Physiologic Function Monitor1Product Code
- FAJCystoscope And Accessories, Flexible/Rigid2Product Code
- FAKPanendoscope (Gastroduodenoscope)2Product Code
- FALPanendoscope (Urethroscope)2Product Code
- FAMSigmoidoscope And Accessories, Flexible/Rigid2Product Code
- FANSigmoidoscope, Rigid, Electrical2Product Code
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device2Product Code
- FBIRongeur, Cystoscopic2Product Code
- FBKEndoscopic Injection Needle, Gastroenterology-Urology2Product Code
- FBNCholedochoscope And Accessories, Flexible/Rigid2Product Code
- FBOCystourethroscope2Product Code
- FBPTelescope, Rigid, Endoscopic2Product Code
- FCCEndoscopic Magnetic Retriever2Product Code
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal2Product Code
- FCGBiopsy Needle2Product Code
- FCIPunch, Biopsy2Product Code
- FCKInstrument, Biopsy, Suction2Product Code
- FCLForceps, Biopsy, Non-Electric1Product Code
- FCOBox, Battery, Rechargeable1Product Code
- FCRLight Source, Photographic, Fiberoptic2Product Code
- FCWLight Source, Fiberoptic, Routine2Product Code
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope2Product Code
- FCYBulb, Inflation, For Endoscope1Product Code
- FCZTube, Smoke Removal, Endoscopic1Product Code
- FDAEnteroscope And Accessories2Product Code
- FDCResectoscope, Working Element2Product Code
- FDELaparoscopy Kit2Product Code
- FDFColonoscope And Accessories, Flexible/Rigid2Product Code
- FDRSphyncteroscope2Product Code
- FDSGastroscope And Accessories, Flexible/Rigid2Product Code
- FDTDuodenoscope And Accessories, Flexible/Rigid2Product Code
- FDWEsophagoscope, Rigid, Gastro-Urology2Product Code
- FDXEndoscopic Cytology Brush2Product Code
- FDYDevice, Measuring, For Panendoscope1Product Code
- FDZAttachment, Eyepiece, For Insertion Of Prescription Lens1Product Code
- FEAAttachment, Teaching, For Endoscope1Product Code
- FECObturator, For Endoscope2Product Code
- FEDEndoscopic Access Overtube, Gastroenterology-Urology2Product Code
- FEIInstrument, Special Lens, For Endoscope1Product Code
- FEJAttachment, Binocular, For Endoscope1Product Code
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)1Product Code
- FENDevice, Cystometric, Hydraulic2Product Code
- FEQPump, Air, Non-Manual, For Endoscope2Product Code
- FERAnoscope And Accessories2Product Code
- FESRecorder, External, Pressure, Amplifier & Transducer2Product Code
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- FFFCover, Biopsy Forceps1Product Code
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable2Product Code
- FFSImage, Illumination, Fiberoptic, For Endoscope2Product Code
- FFTElectrode, Ph, Stomach1Product Code
- FFXSystem, Gastrointestinal Motility (Electrical)2Product Code
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope1Product Code
- FFZCord, Electric, For Endoscope2Product Code
- FGAKit, Nephroscope2Product Code
- FGBUreteroscope And Accessories, Flexible/Rigid2Product Code
- FGCUrethroscope2Product Code
- FGSCarrier, Sponge, Endoscopic2Product Code
- FHOPneumoperitoneum Needle2Product Code
- FHPNeedle, Pneumoperitoneum, Simple2Product Code
- FHXJelly, Lubricating, For Transurethral Surgical Instrument2Product Code
- FJLResectoscope2Product Code
- FTILamp, Endoscope, Incandescent2Product Code
- FTJColonoscope, General & Plastic Surgery2Product Code
- GCFProctoscope2Product Code
- GCKGastroscope, General & Plastic Surgery2Product Code
- GCLEsophagoscope, General & Plastic Surgery2Product Code
- GCMEndoscope, Rigid2Product Code
- GCNEndoscope, Prism2Product Code
- GCOEndoscope, Mirror2Product Code
- GCPEndoscope, Ac-Powered And Accessories2Product Code
- GCQEndoscope, Flexible2Product Code
- GCSEndoscope, Battery-Powered And Accessories2Product Code
- GCTLight Source, Endoscope, Xenon Arc2Product Code
- GCWTransformer, Endoscope2Product Code
- GDBEndoscope, Fiber Optic2Product Code
- KDMSigmoidoscope, Rigid, Non-Electrical2Product Code
- KDORongeur, Cystoscopic, Hot2Product Code
- KGDScissors For Cystoscope2Product Code
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2Product Code
- KNWInstrument, Biopsy2Product Code
- K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)2Cleared 510(K)
- K242322Bone Marrow Biopsy Needle2Cleared 510(K)
- K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle2Cleared 510(K)
- K242228Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)2Cleared 510(K)
- K243095Mammotome AutoCore™ Single Insertion Core Biopsy System2Cleared 510(K)
- K242029TRAP EASY2Cleared 510(K)
- K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)2Cleared 510(K)
- K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM2Cleared 510(K)
- K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle2Cleared 510(K)
- K230646SUREcore Prime Biopsy Instrument2Cleared 510(K)
- K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)2Cleared 510(K)
- K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver2Cleared 510(K)
- K223300Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument2Cleared 510(K)
- K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle2Cleared 510(K)
- K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)2Cleared 510(K)
- K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)2Cleared 510(K)
- K220611SUREcore Plus Biopsy Instrument2Cleared 510(K)
- K220595NeoNavia Biopsy System2Cleared 510(K)
- K212820Disposable Semi Automatic Biopsy Instrument2Cleared 510(K)
- K213232NovaCore Semi-Automatic Biopsy Instrument2Cleared 510(K)
- K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle2Cleared 510(K)
- K213683Promisemed Fine Biopsy Needle2Cleared 510(K)
- K213896BD Trek Powered Bone Biopsy System2Cleared 510(K)
- K212079TeesuVac Breast Biopsy Device Mark 12Cleared 510(K)
- K213213Arthrex Vortex Threaded Bone Marrow Recovery Needle2Cleared 510(K)
- K212284Disposable Automatic Core Biopsy Instrument2Cleared 510(K)
- K203141Uramix CuraWay Biopsy Needle2Cleared 510(K)
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles2Cleared 510(K)
- K211933EleVation Breast Biopsy System2Cleared 510(K)
- K210654EnCor Breast Biopsy Probe with Rinse Tube2Cleared 510(K)
- K210631Avitus(r) Bone Harvester2Cleared 510(K)
- K201650VMCore Biopsy Needle2Cleared 510(K)
- K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm2Cleared 510(K)
- K202287Ran-Flex-B Bone Marrow Aspiration Needle2Cleared 510(K)
- K201166Temno Elite Biopsy System2Cleared 510(K)
- K202012Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System2Cleared 510(K)
- K201244Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices2Cleared 510(K)
- K192101Medone Ultra, Medextra2Cleared 510(K)
- K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System2Cleared 510(K)
- K200278CytoCore2Cleared 510(K)
- K193268APrioCore Plus2Cleared 510(K)
- K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G2Cleared 510(K)
- K191315Remington Medical, Inc. Automatic Cutting Needle (NAC)2Cleared 510(K)
- K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,2Cleared 510(K)
- K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix2Cleared 510(K)
- K183146Ranfac Cartilage Biopsy Needle2Cleared 510(K)
- K181803Medax Biopsy Systems III2Cleared 510(K)
- K171890BEXCORE Breast Biopsy System, Biopsy Needle2Cleared 510(K)
- K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device2Cleared 510(K)
- K180807Celling Aspiration Needle2Cleared 510(K)
- K180233Eviva Stereotactic Guided Breast Biopsy System2Cleared 510(K)
- K180450Corvocet Biopsy System2Cleared 510(K)
- K180327Stryker iVAS 13g Bone Biopsy Kit2Cleared 510(K)
- K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)2Cleared 510(K)
- K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit2Cleared 510(K)
- K171953Bard Mission Disposable Core Biopsy Instrument2Cleared 510(K)
- K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle2Cleared 510(K)
- K162588Möller Medical Biopsy Needles and Systems2Cleared 510(K)
- K163052Brevera Biopsy System with Corlumina Imaging Technology2Cleared 510(K)
- K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm2Cleared 510(K)
- K170008Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set2Cleared 510(K)
- K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles2Cleared 510(K)
- K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet2Cleared 510(K)
- K161234CASSI II Rotational Core Biopsy System2Cleared 510(K)
- K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem2Cleared 510(K)
- K161805EnCor MRI Introducer Set, EnCor Probe Introducer2Cleared 510(K)
- K153337Corvocet Biopsy System2Cleared 510(K)
- K152989Mammotome revolve Dual Vacuum Assist Biopsy System2Cleared 510(K)
- K152596Intact® Gen2 System2Cleared 510(K)
- K152872K2M Fenestrated Tap System2Cleared 510(K)
- K142125New Medax Biopsy Systems2Cleared 510(K)
- K153306Imbibe Needle2Cleared 510(K)
- K152474Avitus Bone Harvester2Cleared 510(K)
- K150169Sertera Biopsy Device2Cleared 510(K)
- K150088Evacore Fully Disposable Vacuum Assist Biopsy Device2Cleared 510(K)
- K150625Morrison Steerable Needle2Cleared 510(K)
- K150563Marrow Cellution Bone Marrow Aspiration Needle2Cleared 510(K)
- K141910Intraosseous Cannula System Bio-MAC¿ and Bio-CORE2Cleared 510(K)
- K143546Imbibe Aspirating XIA Taps2Cleared 510(K)
- K142791Spectra Soft Tissue Biopsy Needles2Cleared 510(K)
- K142377The OnControl Bone Marrow Biopsy System by Vidacare2Cleared 510(K)
- K142477Intact Advance and Intact Excision XL, Intact BLES2Cleared 510(K)
- K140991RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE2Cleared 510(K)
- K141552ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS2Cleared 510(K)
- K141673IVAS 8 GAUGE BONE BIOPSY KIT2Cleared 510(K)
- K133702PRESTO BREAST BIOPSY DEVICE2Cleared 510(K)
- K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT2Cleared 510(K)
- K130616MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES2Cleared 510(K)
- K131157RANFAC BONE MARROW ASPIRATION NEEDLE2Cleared 510(K)
- K130282REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT2Cleared 510(K)
- K123606CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE2Cleared 510(K)
- K123259MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM2Cleared 510(K)
- K121181SWANNSHIDI BONE MARROW ASPIRATION NEEDLE2Cleared 510(K)
- K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE2Cleared 510(K)
- K120440PRESTO BREAST BIOPSY DEVICE2Cleared 510(K)
- K112411MAMMOTOME ELITE BIOPSY SYSTEM2Cleared 510(K)
- K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE2Cleared 510(K)
- K120189BONETRAP2Cleared 510(K)
- K102756SURECORE BIOPSY DEVICE2Cleared 510(K)
- K113209CHIBA SONO2Cleared 510(K)
- K112945ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM2Cleared 510(K)
- K112468THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE2Cleared 510(K)
- K111765FULL CORE BIOPSY SYSTEM2Cleared 510(K)
- K111529MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-2Cleared 510(K)
- K102771BIOPSY HANDY, MRI BIOPSY HANDY2Cleared 510(K)
- K111100ENCOR ENSPIRE BREAST BIOPSY SYSTEM2Cleared 510(K)
- K110883J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA2Cleared 510(K)
- K092338MEDAX UNIPERSONALE SRL2Cleared 510(K)
- K103359FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)2Cleared 510(K)
- K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT2Cleared 510(K)
- K093899MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING2Cleared 510(K)
- K093512ENCOR BREAST BIOPSY SYSTEM2Cleared 510(K)
- K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 6705202Cleared 510(K)
- K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 9920182Cleared 510(K)
- K093068FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US2Cleared 510(K)
- K092059RP CUTTING NEEDLE2Cleared 510(K)
- K090611REVOLUTION FULL CORE BIOPSY2Cleared 510(K)
- K082681VACORA VACUUM ASSISTED BIOPSY SYSTEM2Cleared 510(K)
- K081057INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL2Cleared 510(K)
- K080095CORAMATE/SPIROTOME SYSTEM2Cleared 510(K)
- K080171SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB30122Cleared 510(K)
- K072045ONCONTROL BONE MARROW BIOPSY SYSTEM2Cleared 510(K)
- K071814LIGHT SABRE SPINAL ACCESS DEVICE2Cleared 510(K)
- K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 315372Cleared 510(K)
- K063233DELTACUT (APPARATUS AND CANNULA)2Cleared 510(K)
- K070091COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC12082Cleared 510(K)
- K063697SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT2Cleared 510(K)
- K062832VACORA 14G BIOPSY PROBES, MODELS VB14116, VB141382Cleared 510(K)
- K060384CORAMATE/SPIROTOME SYSTEM2Cleared 510(K)
- K061570I-STYLE BONE MARROW ASPIRATION NEEDLE2Cleared 510(K)
- K060413INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE2Cleared 510(K)
- K053151RUBICOR MAGIC BREAST BIOPSY DEVICE2Cleared 510(K)
- K052638ABBOTT SPINE, INC. SPINNAKER SYSTEM2Cleared 510(K)
- K052435PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS2Cleared 510(K)
- K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE2Cleared 510(K)
- K051581SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS20002Cleared 510(K)
- K051361EASY CORE DETACHABLE BIOPSY SYSTEM2Cleared 510(K)
- K050795IMBIBE BONE MARROW ASPIRATION NEEDLE2Cleared 510(K)
- K051158ENCOR 7 GAUGE2Cleared 510(K)
- K043523INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE2Cleared 510(K)
- K042753MAMMOTOME MR BIOPSY SYSTEM2Cleared 510(K)
- K042290VACUUM ASSISTED CORE BIOPSY DEVICE2Cleared 510(K)
- K042464V-CORE FULL CORE BREAST BIOPSY INSTRUMENT2Cleared 510(K)
- K042136SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM2Cleared 510(K)
- K034021VACUUM ASSISTED CORE BIOPSY DEVICE2Cleared 510(K)
- K041544COOK SIDEARM CORE TISSUE BIOPSY DEVICE2Cleared 510(K)
- K040266CORE NEEDLE BIOPSY2Cleared 510(K)
- K040842SENORX BIOPSY DEVICE II2Cleared 510(K)
- K040087RABBIT2Cleared 510(K)
- K033616TRAPMATIC SYSTEM SET2Cleared 510(K)
- K033700MAMMOTOME EX HAND HELD SYSTEM2Cleared 510(K)
- K032943STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS2Cleared 510(K)
- K033427MODIFICATION TO EN-BLOC BIOPSY SYSTEM2Cleared 510(K)
- K032506SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM2Cleared 510(K)
- K030472MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM2Cleared 510(K)
- K032847EXCISOR BIOPTOME, MODEL 01-00042Cleared 510(K)
- K031344RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE2Cleared 510(K)
- K030443MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST2Cleared 510(K)
- K024089VACUFLASH BIOPSY SYSTEM2Cleared 510(K)
- K023923SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE2Cleared 510(K)
- K022286ENCIRCLE LOCALIZATION DEVICE2Cleared 510(K)
- K022879MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY2Cleared 510(K)
- K020848NAFD 1002Cleared 510(K)
- K021707SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS2Cleared 510(K)
- K022169CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES2Cleared 510(K)
- K021137SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM2Cleared 510(K)
- K020987BMN I TYPE MARROW ASPIRATION NEEDLE2Cleared 510(K)
- K020867BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL2Cleared 510(K)
- K013108BIOSUC2Cleared 510(K)
- K020024CARIS MINITOME BIOPSY INSTRUMENT2Cleared 510(K)
- K013692TRAPSYSTEM SET2Cleared 510(K)
- K012088NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT2Cleared 510(K)
- K012023ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE2Cleared 510(K)
- K012224SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW2Cleared 510(K)
- K01157522MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD0222Cleared 510(K)
- K010735SPEEDYBELL2Cleared 510(K)
- K010400VACUUM ASSISTED CORE BIOPSY DEVICE2Cleared 510(K)
- K011206PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES2Cleared 510(K)
- K011104OSTEOBELL2Cleared 510(K)
- K003528SANARUS CORE TISSUE BIOPSY SYSTEM2Cleared 510(K)
- K010037DAUM DOUBLE-SHOOT BISOPSY GUN2Cleared 510(K)
- K003297MAMMOTOME HAND HELD PROBE, MODEL MHH82Cleared 510(K)
- K003439VIVANT BREAST LESION LOCALIZATION DEVICE2Cleared 510(K)
- K003370JAMSHIDI MARROW ACQUISITION CRADLE2Cleared 510(K)
- K002546CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE2Cleared 510(K)
- K001132BONE BIOPSY NEEDLE2Cleared 510(K)
- K000612ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE2Cleared 510(K)
- K000135PRO.DUCT CATHETER, MODEL CTH032Cleared 510(K)
- K994272AUTOMATED CORE BIOPSY DEVICE2Cleared 510(K)
- K99393615MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE2Cleared 510(K)
- K993342DUCPREP BREAST ASPIRATOR, MODEL PMPO22Cleared 510(K)
- K993435MANUAL BONE MARROW BIOPSY DEVICE2Cleared 510(K)
- K99281311 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT2Cleared 510(K)
- K991980MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,2Cleared 510(K)
- K992499GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE2Cleared 510(K)
- K991366DAUM MRI/CONVENTIONAL BIOPSY KIT2Cleared 510(K)
- K983867FUJI CATHETER, MODEL CTH0012Cleared 510(K)
- K983296AUTO SUTURE ABBI SYSTEM2Cleared 510(K)
- K990839TRU-CORE I REUSABLE BIOPSY INSTRUMENT2Cleared 510(K)
- K990645GALLINI ATRA-CUT NEEDLE2Cleared 510(K)
- K990716GALLINI BYCUT NEEDLE2Cleared 510(K)
- K990515MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM2Cleared 510(K)
- K990782DAUM NEUROGATE TROCAR2Cleared 510(K)
- K990278DAUM NEUROCUT NEUROBIOPSYNEEDLE2Cleared 510(K)
- K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE2Cleared 510(K)
- K982960MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT2Cleared 510(K)
- K982735LIGHT SABER BONE BIOPSY NEEDLE2Cleared 510(K)
- K982401PROSTATE BIOPSY NEEDLE2Cleared 510(K)
- K981796LIGHT SABER CORE TISSUE NEEDLE2Cleared 510(K)
- K981721C0-AXIAL INTRODUCER NEEDLE2Cleared 510(K)
- K982085MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT2Cleared 510(K)
- K981301SPEED-CUT AUTOMATIC BIOPSY SYSTEM2Cleared 510(K)
- K972328PERCUTANEOUS BREAST BIOPSY (PBB)2Cleared 510(K)
- K981320DAUM BONE BIOPSY SET2Cleared 510(K)
- K981166ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 5812142Cleared 510(K)
- K981477MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE2Cleared 510(K)
- K980676SPIGAL NEEDLE2Cleared 510(K)
- K980479QUICK-CUT AUTOMATIC BIOPSY SYSTEM2Cleared 510(K)
- K963794PUNCTURENEEDLE2Cleared 510(K)
- K974631DAUM NEUROBIOPSY NEEDLE2Cleared 510(K)
- K974575DAUM ASPIRATIONBIOPSY NEEDLE2Cleared 510(K)
- K974574DAUM NEUROPUNCTURE NEEDLE2Cleared 510(K)
- K974576DAUM BIOPSYGUN2Cleared 510(K)
- K980452MANAN LIVER BIOPSY KIT2Cleared 510(K)
- K980248ACRI R NEEDLE2Cleared 510(K)
- K980226MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM2Cleared 510(K)
- K980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES2Cleared 510(K)
- K980196MD TECH BIOPSY SET FOR BONE AND BONE MARROW2Cleared 510(K)
- K980122MANAN SOFT TISSUE BIOPSY NEEDLES2Cleared 510(K)
- K974440IBI2Cleared 510(K)
- K980068WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE2Cleared 510(K)
- K974794WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE2Cleared 510(K)
- K974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR2Cleared 510(K)
- K980004MANAN GENERAL PURPOSE INTRODUCER NEEDLE2Cleared 510(K)
- K974814MANAN(TM) SUPER-CORE BIOPSY NEEDLES2Cleared 510(K)
- K973152GALLINI ABS DEVICE2Cleared 510(K)
- K974766MANAN TECHNA-CUT ASPIRATION NEEDLE2Cleared 510(K)
- K974446MANAN AUTOMATIC CUTTING NEEDLE2Cleared 510(K)
- K974158ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY2Cleared 510(K)
- K972496PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER2Cleared 510(K)
- K973496THE AUTO SUTURE* MIBB** SYSTEM2Cleared 510(K)
- K973215STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM2Cleared 510(K)
- K973565QUICK-CARE BIOPSY NEEDLE2Cleared 510(K)
- K962977MRI COMPATIBLE BIOPSY NEEDLES2Cleared 510(K)
- K972266GALLINI COAXIAL INTRODUCER2Cleared 510(K)
- K970871TR NEEDLE2Cleared 510(K)
- K970872PAN (CHIBA ASPIRATING NEEDLE)2Cleared 510(K)
- K970565MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)2Cleared 510(K)
- K963813SURE CORE BIOPSY KIT2Cleared 510(K)
- K964777TZ2Cleared 510(K)
- K963825AUTO SUTURE* ABBI* SYSTEM2Cleared 510(K)
- K962969MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA2Cleared 510(K)
- K961407SPEED-CUT2Cleared 510(K)
- K962907SKINNY,FRANSEEN,WESCOTT NEEDLES2Cleared 510(K)
- K963390BIOPSY INTRODUCER NEEDLE2Cleared 510(K)
- K962077BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER2Cleared 510(K)
- K960064TEMNO ACHIEVE BIOPSY NEEDLE2Cleared 510(K)
- K960065TEMNO DOUBLE SHOT BIOPSY NEEDLE2Cleared 510(K)
- K96050918 GAUGE TRU-CUT BIOPSY NEEDLE2Cleared 510(K)
- K954999LILY MULTICANNULA GUIDE2Cleared 510(K)
- K954529AUTOMATED TRU-CUT BIOPSY DEVICE2Cleared 510(K)
- K953399NEEDLE OR CUTTER2Cleared 510(K)
- K954265TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE2Cleared 510(K)
- K954151BIOACCESS BONE BIOPSY SYSTEM2Cleared 510(K)
- K953923URESIL INTRODUCING NEEDLE2Cleared 510(K)
- K953880BIOPSY NEEDLE2Cleared 510(K)
- K951229MODIFIED BIOPSY NEEDLE2Cleared 510(K)
- K950732MANAN SUPER-CORE BIOPSY NEEDLE2Cleared 510(K)
- K945573BIOPSY DEVICE ACCESSORY2Cleared 510(K)
- K944837MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE2Cleared 510(K)
- K943651TECHNA-CUT ASPIRATION NEEDLE2Cleared 510(K)
- K943650LIVER BIOPSY KIT2Cleared 510(K)
- K943368TRU-CORE NEEDLE SET2Cleared 510(K)
- K941256QUICK CORE II2Cleared 510(K)
- K942630WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE2Cleared 510(K)
- K942639BIOPSY NEEDLE AND HOUSING2Cleared 510(K)
- K934371BIP MULTI MODIFICATION2Cleared 510(K)
- K941549BIOPSY NEEDLE AND HOUSING2Cleared 510(K)
- K935814MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE2Cleared 510(K)
- K940365MANAN ADAPTER FOR BARD BIOPTY SYSTEM2Cleared 510(K)
- K933448MANAN ADAPTER FOR BIP BIOPSY DEVICE2Cleared 510(K)
- K930201ACECUT SUTOMATIC BIOPSY SYSTEM2Cleared 510(K)
- K930083EMS BIOPSY INSTRUMENT2Cleared 510(K)
- K930241OLYMPUS DISPOSABLE BIOPSY FORCEPS2Cleared 510(K)
- K922939BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.2Cleared 510(K)
- K924106BIOPSY FORCEPS2Cleared 510(K)
- K922161GRICE SOFT TISSUE BIOPSY KIT2Cleared 510(K)
- K922879MEADOX SURGIMED BIOPSY GUN III2Cleared 510(K)
- K914215SELECTACUT BIOPSY DEVICE2Cleared 510(K)
- K914874MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE2Cleared 510(K)
- K912892AUTO-VAC BIOPSY NEEDLE2Cleared 510(K)
- K913098APIRATION BIOPSY SYRINGE GUN, CAT. CODE #545012Cleared 510(K)
- K910190BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT2Cleared 510(K)
- K911635MEADOX(R) SURGIMED(R) BIOPSY GUN II2Cleared 510(K)
- K905557CCC CROWN-CORE-CUT-NEEDLE2Cleared 510(K)
- K904987VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)2Cleared 510(K)
- K904658AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV2Cleared 510(K)
- K902066DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES2Cleared 510(K)
- K902077T19S BIOPSY NEEDLE2Cleared 510(K)
- K902461MEADOX SURGIMED BIOPSY GUN AND NEEDLE2Cleared 510(K)
- K900082MAXX 470 CORE BIOPSY GUN2Cleared 510(K)
- K896933INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN2Cleared 510(K)
- K901339BIOPSY FORCEPS (NON-RIGID)2Cleared 510(K)
- K895457MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES2Cleared 510(K)
- K894419GASTRO ENTEROLOGICAL BIOPTOME2Cleared 510(K)
- K893992NOETIX, BIOPSY NEEDLE2Cleared 510(K)
- K892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE2Cleared 510(K)
- K882746ADMS SILENT NEEDLE GUN2Cleared 510(K)
- K885169STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE2Cleared 510(K)
- K884900SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER2Cleared 510(K)
- K883469BARD(R) ASPIRATION BIOPSY SYSTEM2Cleared 510(K)
- K883884PROSTATIC CORE-CUT NEEDLE2Cleared 510(K)
- K883374BARD BIOPSY NEEDLE GUIDANCE DEVICE2Cleared 510(K)
- K881956NATIONAL-STANDARD NEEDLE HOLDER2Cleared 510(K)
- K881957HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT2Cleared 510(K)
- K880098VAN-TEC AUTO BIOPSY NEEDLE2Cleared 510(K)
- K880096VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP2Cleared 510(K)
- K874062ENTERON LIVER BIOPSY TRAY2Cleared 510(K)
- K873996CAREY CAPSULE2Cleared 510(K)
- K874314WILSON-COOK BIOPSY FORCEPS2Cleared 510(K)
- K873369SECURLINE FRANSEENE NEEDLE2Cleared 510(K)
- K873208MANAN TURNER STYLE NEEDLE2Cleared 510(K)
- K871390BARD BIOPTY BIOPSY SYSTEM2Cleared 510(K)
- K870785SOFT TISSUE BIOPSY NEEDLE2Cleared 510(K)
- K870735PROSTATIC ASPIRATION BIOPSY SET2Cleared 510(K)
- K870734TEFLON BIOPSY CATHETER W/TIP ANGLE2Cleared 510(K)
- K861267UROCUT BIOPSY NEEDLE2Cleared 510(K)
- K864329MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT2Cleared 510(K)
- K862562PUNCH BIOPSY KIT2Cleared 510(K)
- K861959BMRI SOFT TISSUE BIOPSY NEEDLE2Cleared 510(K)
- K855003BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N27322Cleared 510(K)
- K854297MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM2Cleared 510(K)
- K854291MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY2Cleared 510(K)
- K850605RADI-BIOPSY DEVICE2Cleared 510(K)
- K851836MANAN MENGHINI NEEDLE2Cleared 510(K)
- K851839MANAN MADAYAG PTC NEEDLE2Cleared 510(K)
- K851838MANAN CHIBA PTC NEEDLE2Cleared 510(K)
- K85179853-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN2Cleared 510(K)
- K851835MANAN GREENE NEEDLE2Cleared 510(K)
- K851837MANAN WESTCOTT NEEDLE2Cleared 510(K)
- K851831MANAN FRANSEENE NEEDLE2Cleared 510(K)
- K851364FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP2Cleared 510(K)
- K850438RENAL BIOPSY TRAY2Cleared 510(K)
- K820293BONE BIOPSY SET2Cleared 510(K)
- K813462MADAYAG TYPE NEEDLE2Cleared 510(K)
- K813085HEPAFIX BIOPSY NEEDLE SET2Cleared 510(K)
- K811454VANCE PROSTATIC ASPIRATION SET2Cleared 510(K)
- K781038HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM2Cleared 510(K)
- K770122PROSTATE BIOPSY NEEDLE2Cleared 510(K)
- K760868VEST RESTRAINT2Cleared 510(K)
- MNKEndoscopic Bite Block1Product Code
- MNLAccessories, Cleaning Brushes, For Endoscope1Product Code
- MYESystem, Electrogastrography (Egg)2Product Code
- NBGMarker, Colon2Product Code
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule2Product Code
- NLMLaparoscope, General & Plastic Surgery, Reprocessed2Product Code
- NLSInstrument, Biopsy, Reprocessed2Product Code
- NLXNeedle, Pneumoperitoneum, Spring Loaded, Reprocessed2Product Code
- NMXNeedle And Needle Set, Gastro-Urology, Reprocessed2Product Code
- NMYNeedle, Endoscopic, Reprocessed2Product Code
- NONForceps, Biopsy, Non-Electric, Reprocessed1Product Code
- NSISystem, Imaging, Esophageal, Wireless, Capsule2Product Code
- NTNLed Light Source2Product Code
- NWBEndoscope, Accessories, Narrow Band Spectrum2Product Code
- NYVGastrointestinal Motility System, Capsule2Product Code
- NWSKit, Choledochoscope, Flexible And Rigid2Product Code
- NWTEndoscopic Cholangiogram Kit2Product Code
- NWUEndoscope Introducer Kit2Product Code
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- OCTAnti Fog Solution And Accessories, Endoscopy2Product Code
- OCUEndoscopic Storage Cover2Product Code
- OCVEndoscope Holder2Product Code
- OCWEndoscopic Tissue Approximation Device2Product Code
- OCXEndoscopic Irrigation/Suction System2Product Code
- OCYEndoscopic Guidewire, Gastroenterology-Urology2Product Code
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered2Product Code
- ODAEndoscopic Central Control Unit2Product Code
- ODBEndoscopic Contamination Prevention Sheath2Product Code
- ODCEndoscope Channel Accessory2Product Code
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula2Product Code
- ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)2Product Code
- ODFMini Endoscope, Gastroenterology-Urology2Product Code
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology2Product Code
- PCVEndoscopic Leak Tester2Product Code
- PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement2Product Code
- PGDColon Capsule Imaging System2Product Code
- PGUSpatial Imaging For Display Of Endoscope Position2Product Code
- PHTBasin For Endoscope Reprocessing1Product Code
- PLLSubmucosal Injection Agent2Product Code
- POZBiopsy Needle Kit2Product Code
- PPENephroscope Set2Product Code
- PRVGastro-Urology Biopsy Kit2Product Code
- PTQEndoscopic Magnetic Retriever, Exempt2Product Code
- QFZGastroenterology-Urology Accessories To A Biopsy Instrument1Product Code
- PTRScissors For Cytoscope, Exempt2Product Code
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt2Product Code
- QIJEndoscopic Transhepatic Venous Access Needle2Product Code
- QISEsophageal, Mucosal, Electrical Characterization2Product Code
- QKZMagnetically Maneuvered Capsule Endoscopy System2Product Code
- QNPGastrointesinal Lesion Software Detection System2Product Code
- SBXSoftware For Endoscopy Procedure Metrics2Product Code
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161409
- 510(k) Type
- Traditional
- Applicant
- Mermaid Medical A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/2016
- Days to Decision
- 74 days
- Submission Type
- Summary