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
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)2Product Code
- HETLaparoscope, Gynecologic (And Accessories)2Product Code
- K221642SIRIUS Endoscope System2Cleared 510(K)
- K210116Video Endoscopy System, 3D Video Endoscopy System2Cleared 510(K)
- K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-52Cleared 510(K)
- K210104SurroundScope System2Cleared 510(K)
- K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))2Cleared 510(K)
- K2002164K UHD Camera System2Cleared 510(K)
- K200638LAP-iX Suction Irrigation2Cleared 510(K)
- K190190WV1 Endoscope2Cleared 510(K)
- K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)2Cleared 510(K)
- K172796Flex Robotic System and Flex Transabdominal Drive2Cleared 510(K)
- K173111LAP-iX Suction Irrigation2Cleared 510(K)
- K163320LAP-Pump PP1102Cleared 510(K)
- K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link2Cleared 510(K)
- K151011VISERA 4K UHD SYSTEM2Cleared 510(K)
- K131656MORCELLEX SIGMA GENERATOR2Cleared 510(K)
- K123365OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-1902Cleared 510(K)
- K111425OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S1902Cleared 510(K)
- K111788ENDOEYE HD II2Cleared 510(K)
- K101458LINA XCISE MODEL MOR-15152Cleared 510(K)
- K091010TROKAMED MORCELLATOR2Cleared 510(K)
- K100280GYNCARE MORCELLEX TISSUE MORCELLATOR2Cleared 510(K)
- K080365MORCE POWER PLUS AND VARIOCARVE MORCELLATOR2Cleared 510(K)
- K081173ENDOSCOPIC CO2 REGULATION UNIT UCR2Cleared 510(K)
- K082451STRYKER VIDEOSCOPE2Cleared 510(K)
- K080948HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH2Cleared 510(K)
- K062097VERESS CANNULA AND MODULAR VERESS CANNULA2Cleared 510(K)
- K062169APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS2Cleared 510(K)
- K061268G-LIX TISSUE GRASPER2Cleared 510(K)
- K061050GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R2Cleared 510(K)
- K050404INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS2Cleared 510(K)
- K043013MILTEX LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K041321VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM2Cleared 510(K)
- K040295APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS2Cleared 510(K)
- K033177POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX2Cleared 510(K)
- K021237COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K022384XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP2Cleared 510(K)
- K022748REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS2Cleared 510(K)
- K020143VASOVIEW 5 HARVESTING CANNULA2Cleared 510(K)
- K003805GYNECOLOGICAL LAPAROSCOPES2Cleared 510(K)
- K010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-12Cleared 510(K)
- K003417MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET2Cleared 510(K)
- K003164TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM2Cleared 510(K)
- K993653MICRO-FRANCE TROCARS AND ACCESSORIES2Cleared 510(K)
- K001220ENDOPATH SURESEAL REDUCER CAP2Cleared 510(K)
- K000199CORTEK MINI LAPAROSCOPE2Cleared 510(K)
- K992513THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF2Cleared 510(K)
- K992481CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF2Cleared 510(K)
- K993801GYNECARE LAPAROSCOPIC MORCELLATOR2Cleared 510(K)
- K990372MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY2Cleared 510(K)
- K992480MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES2Cleared 510(K)
- K990732LAP-WAVE 3000 (P07)2Cleared 510(K)
- K990004DCI ENDOSCOPE2Cleared 510(K)
- K982276BAHO AUTOCLAVABLE LAPAROSCOPE2Cleared 510(K)
- K982515POWER-DRIVE, WISAP MODEL #7688PD/7688PD12Cleared 510(K)
- K982518AQUA PURATOR-BIOTHERM, WISAP MODEL # 16082Cleared 510(K)
- K982428CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)2Cleared 510(K)
- K982149SMITH & NEPHEW DYONICS MICROLAPAROSCOPE2Cleared 510(K)
- K981130KSEA ENDO TIP SYSTEM2Cleared 510(K)
- K970712LAPARO-TENSER2Cleared 510(K)
- K974763DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA2Cleared 510(K)
- K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS2Cleared 510(K)
- K980694KSEA PLASTIC TROCARS2Cleared 510(K)
- K972647CO2 PNEUMO-DISSECTOR2Cleared 510(K)
- K980166LIGHTSOURCE OR ILLUMINATOR2Cleared 510(K)
- K972488KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES2Cleared 510(K)
- K962985KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES2Cleared 510(K)
- K973737MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M2Cleared 510(K)
- K973304MVM 3.3 MM MICROENDOSCOPE2Cleared 510(K)
- K971836VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR2Cleared 510(K)
- K971896GALILEO HIGH RESOLUTION MICRO COUPLER2Cleared 510(K)
- K971837VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 8202Cleared 510(K)
- K962777AMR MINI-LAPAROSCOPE2Cleared 510(K)
- K971797LAPAROSCOPIC BLADDER NECK SUSPENSION KIT2Cleared 510(K)
- K965045TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE2Cleared 510(K)
- K971255IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER2Cleared 510(K)
- K963076LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY2Cleared 510(K)
- K965121CANNULA2Cleared 510(K)
- K970151INTERCEPTRE LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K965055IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES2Cleared 510(K)
- K970105RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS2Cleared 510(K)
- K960640S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)2Cleared 510(K)
- K962246RIGID FIBER OPTIC LAPAROSCOPE2Cleared 510(K)
- K964436WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM2Cleared 510(K)
- K964379KSEA PUNCTURE CANNULA2Cleared 510(K)
- K963872FEMRX MORCELLATOR SYSTEM2Cleared 510(K)
- K964450SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT2Cleared 510(K)
- K963960KSEA UNIMAT PLUS2Cleared 510(K)
- K963949KSEA UNIMAT PLUS2Cleared 510(K)
- K960299PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE2Cleared 510(K)
- K960810BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM2Cleared 510(K)
- K962090KARL STORZ MODEL 203210 O1 UNIMAT PLUS2Cleared 510(K)
- K963359INSUFFLATION NEEDLE2Cleared 510(K)
- K961860A4907 LENS CLEANING SHEATH2Cleared 510(K)
- K961922RDP-22Cleared 510(K)
- K960936RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]2Cleared 510(K)
- K960347SAFETY TROCER WITH SPRINGLOADED OBDURATOR2Cleared 510(K)
- K954774SHIELDED TROCAR (OBTURATOR)2Cleared 510(K)
- K950335KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY2Cleared 510(K)
- K955412A.S.D. SAFETY TROCAR2Cleared 510(K)
- K954775FLO-STAT FLUID MONITORING SYSTEM2Cleared 510(K)
- K960262CORING MORCELLATOR2Cleared 510(K)
- K951343KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES2Cleared 510(K)
- K955403OES LAPARO-THORACO VIDEOSCOPE TYPE V2Cleared 510(K)
- K955456OES LAPARO-THORACO VIDEOSCOPE (RIGID)2Cleared 510(K)
- K942389TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES2Cleared 510(K)
- K953360R-MED ABDOMINAL WALL ELEVATOR2Cleared 510(K)
- K952889INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS2Cleared 510(K)
- K953364SPECULITE2Cleared 510(K)
- K943305OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM2Cleared 510(K)
- K953809KARL STORZ TAKE-APART BIOPOLAR FORCEPS2Cleared 510(K)
- K942838OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN2Cleared 510(K)
- K951105KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP2Cleared 510(K)
- K954520MICROSURGE VERESS NEEDLE2Cleared 510(K)
- K942431LAPOROSCOPIC SCISSORS2Cleared 510(K)
- K953190KSEA MODEL 203200 20 UNIMAT2Cleared 510(K)
- K953574NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER2Cleared 510(K)
- K940265PATTON LAPAROSCOPIC CATHETER INTRODUCER SET2Cleared 510(K)
- K953548LAPAROSCOPIC SURGICAL INSTRUMENT2Cleared 510(K)
- K944200HI-Q HAND INSTRUMENTS, OB/GYN USE2Cleared 510(K)
- K951250KARL STORZ SUCTION CATHETERS2Cleared 510(K)
- K952508FLOW-THERME, WISAP #76422Cleared 510(K)
- K943100STRYKER OPERATING LAPAROSCOPE2Cleared 510(K)
- K944270CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS2Cleared 510(K)
- K941206DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE2Cleared 510(K)
- K951394KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE2Cleared 510(K)
- K950962KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT2Cleared 510(K)
- K946380NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)2Cleared 510(K)
- K943713TORCARS,CANNULAE,SHEATHS,OBTURATORS2Cleared 510(K)
- K951190KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE2Cleared 510(K)
- K951490LASEVAC2Cleared 510(K)
- K946147KSE STEINER ELECTROMECHANIC MORCELLATOR2Cleared 510(K)
- K943662LAPARASCOPE2Cleared 510(K)
- K950108R-MED MINI-RETRACTOR2Cleared 510(K)
- K946359KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS2Cleared 510(K)
- K950457CANNUAL AND TROCAR, SUPERPUBIC2Cleared 510(K)
- K945685KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS2Cleared 510(K)
- K942730AESCULAP LAPAROSCOPES2Cleared 510(K)
- K942411R-MED DISPOSABLE PLUG2Cleared 510(K)
- K945211KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE2Cleared 510(K)
- K943603AESCULAP LAPAROSCOPIC ANCILLARY DEVICES2Cleared 510(K)
- K945982KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER2Cleared 510(K)
- K943053KSEA SEMM TISSUR PUNCH2Cleared 510(K)
- K932779BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.2Cleared 510(K)
- K950232LAPAROSCOPE AND ACCESSORIES FOR OB/GYN2Cleared 510(K)
- K941507THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM2Cleared 510(K)
- K932387CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL2Cleared 510(K)
- K945741TROCAR AND CANNULA ACCESSORY2Cleared 510(K)
- K932276CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #263100202Cleared 510(K)
- K942973HASSON STABILIZING ACCESS CANNULA (SAC)2Cleared 510(K)
- K946235CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE2Cleared 510(K)
- K944268CIT TWO WAY SUCTIN AND IRRIGATION TUBES2Cleared 510(K)
- K943810IMAGYN MICROLAP INTRODUCER2Cleared 510(K)
- K945100KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE2Cleared 510(K)
- K944269CIT GRASPING AND DISSECTING FORCEPS2Cleared 510(K)
- K944079IMAGYN MICROLAP(TM) LAPAROSCOPE2Cleared 510(K)
- K936273STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 3602Cleared 510(K)
- K944555ENDOSCOPE2Cleared 510(K)
- K944563FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS2Cleared 510(K)
- K934799CONMED TROGARD2Cleared 510(K)
- K942447HASSON OPEN LAPAROSCOPY CANNULA2Cleared 510(K)
- K931065LAPAROVIEW2Cleared 510(K)
- K943508INSUFFLATOR TUBING WITH FILTER2Cleared 510(K)
- K944245DYNABITE LAPAROSCOPIC FORCEPS2Cleared 510(K)
- K944129IMAGYN LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K943598FLEXIBLE FIBER OPTIC LAPAROSCOPES2Cleared 510(K)
- K931478ZEISS OPMI L STEREO-LAPAROSCOPE2Cleared 510(K)
- K936011INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM2Cleared 510(K)
- K926259SURGIMAT2Cleared 510(K)
- K925079LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)2Cleared 510(K)
- K936071SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE2Cleared 510(K)
- K941944TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE2Cleared 510(K)
- K940718INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS2Cleared 510(K)
- K921294VIDEO ENDOSCOPE-RIGID MODIFICATION2Cleared 510(K)
- K926597LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)2Cleared 510(K)
- K924611IRRIGATION PUMP AND TUBING SET2Cleared 510(K)
- K933768COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES2Cleared 510(K)
- K940505ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)2Cleared 510(K)
- K941208DIAGNOSTIC SLEEVE, REDUCER SLEEVE2Cleared 510(K)
- K941334DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE2Cleared 510(K)
- K926596OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K923260LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED2Cleared 510(K)
- K926594OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES2Cleared 510(K)
- K940709SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS2Cleared 510(K)
- K935785KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES2Cleared 510(K)
- K941094INSUFFLATION TUBING & FILTER2Cleared 510(K)
- K940462HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION2Cleared 510(K)
- K940049KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS2Cleared 510(K)
- K940844MYOMA DRILL 5MM-8383.6112Cleared 510(K)
- K921722BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA2Cleared 510(K)
- K925968ENDOSCOPE2Cleared 510(K)
- K935031RIZA-RIBE NEEDLE2Cleared 510(K)
- K931771BIRTCHER ENDOSCOPIC CORKSCREW2Cleared 510(K)
- K931654BIRTCHER MAGNETIC RETRIEVER (GS-3100)2Cleared 510(K)
- K941494ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS2Cleared 510(K)
- K932689LAPRO-LOADER(TM)2Cleared 510(K)
- K923259LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS2Cleared 510(K)
- K926021NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE2Cleared 510(K)
- K933492ESYS SYSTEM2Cleared 510(K)
- K934506DYNABITE HYSTEROSCOPIC FORCEPS2Cleared 510(K)
- K934451HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS2Cleared 510(K)
- K933698100 SERIES ENDOSCOPIC GRASPING FORCEPS2Cleared 510(K)
- K933130TROGARD TROCAR SLEEVE RETAINING THREAD2Cleared 510(K)
- K932118ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET2Cleared 510(K)
- K933008RETRACTORS AND SCRAPER2Cleared 510(K)
- K930934ENDOPATH RELOADABLE LINEAR CUTTER2Cleared 510(K)
- K915857FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE2Cleared 510(K)
- K930756LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE2Cleared 510(K)
- K924485LAPAROSCOPY SET2Cleared 510(K)
- K932832PRIMUS INSULATED FORCEPS2Cleared 510(K)
- K932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES2Cleared 510(K)
- K922248MALLAWANY ATRAUMATIC TISSUE FORCEPS2Cleared 510(K)
- K931561TROCAR SLEEVE2Cleared 510(K)
- K921335ULTRAFLOW SUCTION-IRRIGATION CANNULA2Cleared 510(K)
- K932072JARIT SURGICAL INSTRUMENTS2Cleared 510(K)
- K932020ENTREE BLUNT TIP TROCAR AND ADAPTER2Cleared 510(K)
- K931501NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.2Cleared 510(K)
- K931136APOLLO CAMERA2Cleared 510(K)
- K923568TROCAR STABILITY THREAD2Cleared 510(K)
- K921716DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM2Cleared 510(K)
- K923636TROCAR W/ BLUNT TIP OBTURATOR2Cleared 510(K)
- K924844BULK TISSUE REMOVAL SYSTEM2Cleared 510(K)
- K923126MALLAWANY TISSUE GRASPING FORCEPS2Cleared 510(K)
- K921417URESIL LAPAROSCOPIC RETRACTOR2Cleared 510(K)
- K922418VIDEO ENDOSCOPE SYSTEM2Cleared 510(K)
- K921015SHARPE ENDOSPONGE ASPIIRATOR2Cleared 510(K)
- K915743SHARPE ENDOTENACULUM2Cleared 510(K)
- K924530CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI2Cleared 510(K)
- K920234DAVOL LAPAROSCOPIC DISSECTORS2Cleared 510(K)
- K921888SHARPE ENDODISSECTOR2Cleared 510(K)
- K915749SHARPE ENDOLIGATURE CARRIER2Cleared 510(K)
- K915744SHARPE ENDOHEMOSTAT2Cleared 510(K)
- K915747SHARPE ENDOFORCEPS2Cleared 510(K)
- K915331AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE2Cleared 510(K)
- K915338CONDUCTIVE SURGIGRIP SPIRAL SLEEVE2Cleared 510(K)
- K920548SHARPE ENDOSCALPEL2Cleared 510(K)
- K920549SHARPE ENDONEEDLE HOLDER2Cleared 510(K)
- K914923UNISURGE DISPOSABLE TROCAR2Cleared 510(K)
- K915378WECK TROCAR2Cleared 510(K)
- K915116TROCAR SHEATH ANCHOR2Cleared 510(K)
- K912093DISPOSABLE ASPIRATION IRRIGATION SYSTEM2Cleared 510(K)
- K913944NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES2Cleared 510(K)
- K913299SOF-FLEX LAPAROSCOPIC BASKET2Cleared 510(K)
- K915297TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM2Cleared 510(K)
- K903663MEDSCOPE 8MM AND 10MM LAPAROSCOPE2Cleared 510(K)
- K914968DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR2Cleared 510(K)
- K912882INNERVISION LAPAROSCOPE AND ACCESSORIES2Cleared 510(K)
- K912398ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF2Cleared 510(K)
- K910921AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV2Cleared 510(K)
- K910907PUMP VAC PLUS2Cleared 510(K)
- K905471TROCAR ACCESS SHEATH2Cleared 510(K)
- K910209LAPAROSCOPIC IRRIGATOR/ASPIRATOR2Cleared 510(K)
- K904848PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE2Cleared 510(K)
- K910015CANNULA INTRODUCTION SET2Cleared 510(K)
- K910713FLYNN TISSUE PROBE AND BLUNT DISSECTOR2Cleared 510(K)
- K910008ENDOTHRED ADJUSTABLE STABILITLY THEREAD2Cleared 510(K)
- K905759HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS2Cleared 510(K)
- K903339VIDEO ENDOSCOPE, RIGID2Cleared 510(K)
- K902197FUJINON EVL-F (TENTATIVE) AND TROCAR2Cleared 510(K)
- K905196LAPAROSCOPE2Cleared 510(K)
- K910579OVARIAN ASPIRATION/IRRIGATION NEEDLE2Cleared 510(K)
- K910340LAPAROSCOPIC ASPIRATION PROBE2Cleared 510(K)
- K904645HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)2Cleared 510(K)
- K905426AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE2Cleared 510(K)
- K904907ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER2Cleared 510(K)
- K904379SURGICAL TROCAR AND CANNULA2Cleared 510(K)
- K903078HASSON STABILIZING ACCESS CANNULA2Cleared 510(K)
- K904173INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS2Cleared 510(K)
- K904143V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES2Cleared 510(K)
- K904142GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS2Cleared 510(K)
- K904104ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR2Cleared 510(K)
- K902722BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM2Cleared 510(K)
- K903560CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS2Cleared 510(K)
- K903780AUTO SUTURE LAPAROSCOPY ACCESSORY KIT2Cleared 510(K)
- K903599ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N2Cleared 510(K)
- K903598ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N2Cleared 510(K)
- K903600ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N2Cleared 510(K)
- K903206AUTO SUTURE(R) ENDOSCOPIC SCISSORS2Cleared 510(K)
- K903187LAPAROSCOPIC CATHERTER2Cleared 510(K)
- K903124LAPAROSCOPIC ACCESS SHEATH SET2Cleared 510(K)
- K903207AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE2Cleared 510(K)
- K902657GYNESCOPE LAPAROSCOPIC FORCEPS2Cleared 510(K)
- K9022585 MM IRRIGATION/ASPIRATION FIBER PROBE2Cleared 510(K)
- K903602ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #82032Cleared 510(K)
- K903601ESPI NON-INSULATED DOUBLE-ACTION GRASPER #82042Cleared 510(K)
- K903597ESPI MICRO SCISSORS, #81502Cleared 510(K)
- K903596ESPI REDUCER SLEEVE, #84152Cleared 510(K)
- K903595ESPI CLAW FORCEP, #8302, 10MM, 30CM2Cleared 510(K)
- K903594ESPI TISSUE GRASPER/NEEDLE HOLDER, #82012Cleared 510(K)
- K903593ESPI APPLICATOR SLEEVE, #84102Cleared 510(K)
- K903592ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH2Cleared 510(K)
- K903591ESPI HOOK/UNIVERSAL SCISSORS, # 81012Cleared 510(K)
- K896524SPIRTOS COAXIAL CATHETER SET2Cleared 510(K)
- K903528LAPAROSCOPE2Cleared 510(K)
- K902563MONOSCOPY(TM) BRAND, TROCAR REDUCER SET2Cleared 510(K)
- K902655GYNESCOPE LAPAROSCOPES2Cleared 510(K)
- K902656GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES2Cleared 510(K)
- K901407CORE DISPOSABLE TROCARS2Cleared 510(K)
- K900988AMCATH SUCTION-IRRIGATION TUBE2Cleared 510(K)
- K896118NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE2Cleared 510(K)
- K895225GYNECOLOGICAL INSTRUMENTATION2Cleared 510(K)
- K897064LAPAROSCOPIC ACCESS SHEATH SET2Cleared 510(K)
- K893715ETHICON DISPOSABLE SURGICAL TROCAR2Cleared 510(K)
- K884781OPTI-POINT2Cleared 510(K)
- K874614SUCTION AND LAVAGE PROBE2Cleared 510(K)
- K874612TITANIUM RODS2Cleared 510(K)
- K874611TITANIUM BACKSTOP WITH SUCTION2Cleared 510(K)
- K880763NEZHAT IRRIGATION PUMP SYSTEM2Cleared 510(K)
- K881010CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO2Cleared 510(K)
- K873115CABOT FIBER LASER PROBE2Cleared 510(K)
- K873598LASER LAPAROSCOPY SET2Cleared 510(K)
- K860192ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE2Cleared 510(K)
- K852680TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG2Cleared 510(K)
- K852901DOUBLE PUNCTURE INSTRUMENTS2Cleared 510(K)
- K852031ENDOPORT 5MM2Cleared 510(K)
- K842498DANIELL DBL PUNCTURE LASER LAPAROSCOPY2Cleared 510(K)
- K831241LASER LAPARAXOPE2Cleared 510(K)
- K823294MEDIGROUP LS-110 LIGHT SOURCE2Cleared 510(K)
- K823297ST-610 NEEDLESCOPE STERILIZATION TRAY2Cleared 510(K)
- K823295MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&2Cleared 510(K)
- K823293MEDIGROUP LG-102 LIGHT GUIDE2Cleared 510(K)
- K813133KEYMED KEY LIGHT2Cleared 510(K)
- K812206LAPAROSCOPE2Cleared 510(K)
- K812199TROCAR & TROCAR SLEEVES2Cleared 510(K)
- K800668CANNULA, W/SHARP OBTURATOR & VERESS NEED2Cleared 510(K)
- K791052ENDOSCOPIC INSTRUMENT2Cleared 510(K)
- K772242LAPAROSCOPY CONSOLE MODEL VIII2Cleared 510(K)
- K772185LAPAROSCOPE W/REMOVABLE OPTICS2Cleared 510(K)
- K771962CAMERA ADAPTER FOR ENDOSCOPES2Cleared 510(K)
- K7719598MM SELF-SEALING TROCAR & CANNULA2Cleared 510(K)
- K77195812MM SELF-SEALING TROCAR & CANNULA2Cleared 510(K)
- K7719648MM TROCAR & CANNUAL W/STOPCOCK2Cleared 510(K)
- K771963SINGLE INCISION TUBAL OCCLU. BAND APPL.2Cleared 510(K)
- K771961DUAL INCISION TUBAL OCCLUS. BAND APPLI.2Cleared 510(K)
- K771960TUBAL OCCLUSION INSERTER/LAPAROSCOPE2Cleared 510(K)
- K770378LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS2Cleared 510(K)
- K770379TROCAR SLEEVE SYSTEM2Cleared 510(K)
- HEWCuldoscope (And Accessories)2Product Code
- HEXColposcope (And Colpomicroscope)2Product Code
- HEZEndoscope, Transcervical (Amnioscope)(And Accessories)2Product Code
- HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)FProduct Code
- HFCAspirator, Endocervical2Product Code
- HFDWasher, Endometrial2Product Code
- HFEBrush, Endometrial2Product Code
- HFFAspirator, Endometrial2Product Code
- HGKEndoscope, Fetal Blood Sampling (And Accessories)2Product Code
- HGWSampler, Blood, Fetal2Product Code
- HHKCurette, Suction, Endometrial (And Accessories)2Product Code
- HIFInsufflator, Laparoscopic2Product Code
- HIGInsufflator, Hysteroscopic2Product Code
- HIHHysteroscope (And Accessories)2Product Code
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)1Product Code
- LHZViscometer, Mucus, Cervical1Product Code
- MKOFalloposcope2Product Code
- MOKVaginoscope And Accessories2Product Code
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic1Product Code
- NMHLaparoscope And Accessories, Gynecologic, Reprocessed2Product Code
- NMILaparoscopic Insufflator And Accessories, Reprocessed1Product Code
- NVTTubing And Tubing/Filter Fits1Product Code
- NWVLaparoscopic Accessories, Gynecologic1Product Code
- NWWHysteroscope Accessories1Product Code
- PCFSampler, Endocervical2Product Code
- OHDGynecological Laparoscopic Kit2Product Code
- OHEForensic Evidence Sexual Assault Kit2Product Code
- OHFCuldocentesis Kit2Product Code
- OHMCesarean Section Tray2Product Code
- OKXTrocar Kit2Product Code
- PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar2Product Code
- OKZEndometrial Sampling Kit2Product Code
- OSVInsufflator, Endoscopic Vessel Harvesting2Product Code
- PTZColposcope (And Colpomicroscope), Exempt2Product Code
- PVSFetal Blood Sampling Kit (Excludes Hiv Testing)2Product Code
- QHZSeal, Cervical, Mechanical, Unpowered1Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K150525
- 510(k) Type
- Traditional
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/20/2015
- Days to Decision
- 263 days
- Submission Type
- Summary