FDA Product Code
FDA Product Code HET — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1720
510(k) Clearances — 338 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | 2025-08-29 | Traditional | PDF ↗ |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 | Traditional | PDF ↗ |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | 2022-12-12 | Traditional | PDF ↗ |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 | Traditional | PDF ↗ |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021-09-17 | Traditional | PDF ↗ |
| K210104 | SurroundScope System | 270surgical , Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | 2021-03-12 | Traditional | PDF ↗ |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020-08-21 | Traditional | PDF ↗ |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 | Special | PDF ↗ |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | 2019-11-01 | Traditional | PDF ↗ |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019-08-29 | Special | PDF ↗ |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | 2018-01-18 | Traditional | PDF ↗ |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2017-11-28 | Traditional | PDF ↗ |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | 2017-03-21 | Traditional | PDF ↗ |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K151011 | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | 2015-10-01 | Traditional | PDF ↗ |
| K131656 | MORCELLEX SIGMA GENERATOR | ETHICON, Inc. | 2013-09-27 | Traditional | PDF ↗ |
| K123365 | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | Olympus Medical Systems Corp. | 2013-03-01 | Traditional | PDF ↗ |
| K111425 | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | Olympus Medical Systems Corp. | 2012-04-20 | Traditional | PDF ↗ |
| K111788 | ENDOEYE HD II | Olympus America, Inc. | 2012-01-13 | Traditional | PDF ↗ |
| K101458 | LINA XCISE MODEL MOR-1515 | Lina Medical Aps | 2011-03-11 | Traditional | PDF ↗ |
| K091010 | TROKAMED MORCELLATOR | Trokamed GmbH | 2011-03-01 | Traditional | PDF ↗ |
| K100280 | GYNCARE MORCELLEX TISSUE MORCELLATOR | ETHICON, Inc. | 2010-03-24 | Traditional | PDF ↗ |
| K080365 | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR | NOUVAG AG | 2009-06-29 | Traditional | PDF ↗ |
| K081173 | ENDOSCOPIC CO2 REGULATION UNIT UCR | Olympus Medical Systems Corporation | 2008-12-23 | Traditional | PDF ↗ |
| K082451 | STRYKER VIDEOSCOPE | Stryker Endoscopy | 2008-12-16 | Traditional | PDF ↗ |
| K080948 | HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH | Olympus Medical Systems Corporation | 2008-09-26 | Traditional | PDF ↗ |
| K062097 | VERESS CANNULA AND MODULAR VERESS CANNULA | PAJUNK GmbH Medizintechnologie | 2006-10-13 | Traditional | PDF ↗ |
| K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2006-08-24 | Traditional | PDF ↗ |
| K061268 | G-LIX TISSUE GRASPER | Usgi Medical | 2006-07-31 | Traditional | PDF ↗ |
| K061050 | GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R | ETHICON, Inc. | 2006-07-14 | Traditional | PDF ↗ |
| K050404 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS | Intuitive Surgical, Inc. | 2005-04-21 | Traditional | PDF ↗ |
| K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | Miltex, Inc. | 2005-03-04 | Traditional | PDF ↗ |
| K041321 | VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM | Richard Wolf Medical Instruments Corp. | 2004-07-09 | Traditional | PDF ↗ |
| K040295 | APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2004-03-12 | Traditional | PDF ↗ |
| K033177 | POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX | Gunter Bissinger Medizintechnik GmbH | 2004-03-11 | Special | PDF ↗ |
| K021237 | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS | CooperSurgical, Inc. | 2003-04-10 | Traditional | PDF ↗ |
| K022384 | XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP | Isolux America | 2002-10-18 | Traditional | PDF ↗ |
| K022748 | REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS | Medical Device Services | 2002-10-09 | Traditional | PDF ↗ |
| K020143 | VASOVIEW 5 HARVESTING CANNULA | Guidant Corporation, Cardiac Surgery | 2002-02-20 | Traditional | PDF ↗ |
| K003805 | GYNECOLOGICAL LAPAROSCOPES | Global Endoscopy, Inc. | 2001-07-22 | Traditional | PDF ↗ |
| K010510 | BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 | A & A Medical, Inc. | 2001-05-16 | Traditional | PDF ↗ |
| K003417 | MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET | Richard Wolf Medical Instruments Corp. | 2001-04-04 | Special | PDF ↗ |
| K003164 | TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM | Richard Wolf Medical Instruments Corp. | 2001-01-08 | Traditional | PDF ↗ |
| K993653 | MICRO-FRANCE TROCARS AND ACCESSORIES | Xomed, Inc. | 2000-06-09 | Traditional | PDF ↗ |
| K001220 | ENDOPATH SURESEAL REDUCER CAP | Ethicon Endo-Surgery, Inc. | 2000-05-16 | Traditional | PDF ↗ |
| K000199 | CORTEK MINI LAPAROSCOPE | Cortek Endoscopy, Inc. | 2000-04-13 | Traditional | PDF ↗ |
| K992481 | CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2000-03-17 | Traditional | PDF ↗ |
| K992513 | THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2000-03-17 | Traditional | PDF ↗ |
| K993801 | GYNECARE LAPAROSCOPIC MORCELLATOR | ETHICON, Inc. | 2000-02-07 | Traditional | PDF ↗ |
| K990372 | MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY | Dr. Fritz GmbH | 1999-10-14 | Traditional | PDF ↗ |
| K992480 | MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES | Medifix, Inc. | 1999-09-23 | Traditional | PDF ↗ |
| K990732 | LAP-WAVE 3000 (P07) | W.O.M. World of Medicine GmbH | 1999-07-23 | Traditional | PDF ↗ |
| K990004 | DCI ENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1999-04-02 | Traditional | PDF ↗ |
| K982276 | BAHO AUTOCLAVABLE LAPAROSCOPE | Microptix Int'L, LLC | 1999-02-18 | Traditional | PDF ↗ |
| K982515 | POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1999-01-19 | Traditional | PDF ↗ |
| K982518 | AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1999-01-14 | Traditional | PDF ↗ |
| K982428 | CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) | Innervision, Inc. | 1998-10-09 | Traditional | PDF ↗ |
| K982149 | SMITH & NEPHEW DYONICS MICROLAPAROSCOPE | Smith & Nephew, Inc. | 1998-09-10 | Traditional | PDF ↗ |
| K981130 | KSEA ENDO TIP SYSTEM | KARL STORZ Endoscopy-America, Inc. | 1998-08-19 | Traditional | PDF ↗ |
| K970712 | LAPARO-TENSER | L & T S.N.C. DI E. Lucini & C. | 1998-07-21 | Traditional | PDF ↗ |
| K974763 | DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA | Deroyal Industries, Inc. | 1998-07-10 | Traditional | PDF ↗ |
| K970968 | BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS | Guenter Bissinger Medizintechnik GmbH | 1998-05-21 | Traditional | PDF ↗ |
| K980694 | KSEA PLASTIC TROCARS | KARL STORZ Endoscopy-America, Inc. | 1998-05-08 | Traditional | PDF ↗ |
| K972647 | CO2 PNEUMO-DISSECTOR | Cook Urological, Inc. | 1998-04-10 | Traditional | PDF ↗ |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | 1998-04-01 | Traditional | PDF ↗ |
| K972488 | KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES | Karl Storz Endoscopy | 1998-01-22 | Traditional | PDF ↗ |
| K962985 | KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K973737 | MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M | Richard Wolf Medical Instruments Corp. | 1997-12-12 | Traditional | PDF ↗ |
| K973304 | MVM 3.3 MM MICROENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1997-12-02 | Traditional | PDF ↗ |
| K971836 | VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR | CooperSurgical, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K971896 | GALILEO HIGH RESOLUTION MICRO COUPLER | Netoptix Corp. | 1997-10-10 | Traditional | PDF ↗ |
| K971837 | VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 | CooperSurgical, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K962777 | AMR MINI-LAPAROSCOPE | Applied Medical Resources | 1997-08-06 | Traditional | PDF ↗ |
| K971797 | LAPAROSCOPIC BLADDER NECK SUSPENSION KIT | Louisville Laboratories, Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K965045 | TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE | Ethicon Endo-Surgery, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K971255 | IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER | Imagyn Medical, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | Louisville Laboratories, Inc. | 1997-04-04 | Traditional | PDF ↗ |
| K965121 | CANNULA | Origin Medsystems, Inc. | 1997-03-20 | Traditional | PDF ↗ |
| K970151 | INTERCEPTRE LAPAROSCOPIC INSTRUMENTS | Smith & Nephew, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K965055 | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES | Imagyn Medical, Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K970105 | RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS | Richard Wolf Medical Instruments Corp. | 1997-03-04 | Traditional | PDF ↗ |
| K960640 | S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1997-02-14 | Traditional | PDF ↗ |
| K962246 | RIGID FIBER OPTIC LAPAROSCOPE | Health Care International Assoc. | 1997-02-07 | Traditional | PDF ↗ |
| K964436 | WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM | Western Surgical Instrument Co. | 1997-01-30 | Traditional | PDF ↗ |
| K964379 | KSEA PUNCTURE CANNULA | KARL STORZ Endoscopy-America, Inc. | 1997-01-29 | Traditional | PDF ↗ |
| K963872 | FEMRX MORCELLATOR SYSTEM | Gynecare Innovation Center | 1997-01-17 | Traditional | PDF ↗ |
| K964450 | SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT | Pilling Weck Group | 1997-01-10 | Traditional | PDF ↗ |
| K963960 | KSEA UNIMAT PLUS | KARL STORZ Endoscopy-America, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K963949 | KSEA UNIMAT PLUS | KARL STORZ Endoscopy-America, Inc. | 1996-12-19 | Traditional | PDF ↗ |
| K960299 | PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE | Richard Wolf Medical Instruments Corp. | 1996-10-28 | Traditional | PDF ↗ |
| K960810 | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM | Marlo Surgical Technology | 1996-10-21 | Traditional | PDF ↗ |
| K962090 | KARL STORZ MODEL 203210 O1 UNIMAT PLUS | KARL STORZ Endoscopy-America, Inc. | 1996-09-30 | Traditional | PDF ↗ |
| K963359 | INSUFFLATION NEEDLE | Applied Medical Resources | 1996-09-24 | Traditional | PDF ↗ |
| K961860 | A4907 LENS CLEANING SHEATH | Olympus America, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K961922 | RDP-2 | Ranfac, Corp. | 1996-08-09 | Traditional | PDF ↗ |
| K960936 | RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] | Origin Medsystems, Inc. | 1996-07-24 | Traditional | PDF ↗ |
| K960347 | SAFETY TROCER WITH SPRINGLOADED OBDURATOR | Spiess Design, Inc. | 1996-07-01 | Traditional | PDF ↗ |
| K954774 | SHIELDED TROCAR (OBTURATOR) | Gabris Surgical Corp. | 1996-06-07 | Traditional | PDF ↗ |
| K950335 | KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY | KARL STORZ Endoscopy-America, Inc. | 1996-05-16 | Traditional | PDF ↗ |
Product code HET · Class II · Obstetrics/Gynecology. Data: openFDA.