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Panels › Obstetrics/Gynecology › Product code HET · Class 2

Laparoscope, Gynecologic (And Accessories)

Regulation 884.1720

0510(k)s in 12 months (338 all time)
0recalls in 12 months (19 all time)
16recalls that name a 510(k)
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Top companies in HET

Company510(k)sRecalls
KARL STORZ Endoscopy-America, Inc.290
Dixon Medical, Inc.120
ETHICON, Inc.111
Applied Medical Resources74
Marlo Surgical Technology100
Baxter Healthcare Corp90
Kli90
Richard Wolf Medical Instruments Corp.90
United States Surgical, A Division of Tyco Healthc90
Olympus America, Inc.80
Decided510(k)Device and applicantCode
Aug 29, 2025K250939SIRIUS Endoscope System (PR-SI-1230)
Precision Robotics (Hong Kong) Limited, HK
HET
Apr 25, 2025K243821i-Cut
A.M.I. Agency For Medical Innovations GmbH, AT
HET
Dec 12, 2022K221642SIRIUS Endoscope System
Precision Robotics (Hong Kong) Limited, CN
HET
Oct 13, 2021K210116Video Endoscopy System, 3D Video Endoscopy System
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN
HET
Sep 17, 2021K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
Olympus Medical Systems Corp., JP
HET
Jul 8, 2021K210104SurroundScope System
270surgical , Ltd., IL
HET
Mar 12, 2021K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
Schoelly Fiberoptic GmbH, DE
HET
Aug 21, 2020K2002164K UHD Camera System
Scivita Medical Technology Co., Ltd., CN
HET
Apr 3, 2020K200638LAP-iX Suction Irrigation
Sejong Medical Co., Ltd., KR
HET
Nov 1, 2019K190190WV1 Endoscope
270surgical , Ltd., IL
HET
Aug 29, 2019K190744ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Olympus Winter & Ibe GmbH, DE
HET
Jan 18, 2018K172796Flex Robotic System and Flex Transabdominal Drive
Medrobotics Corporation
HET
Nov 28, 2017K173111LAP-iX Suction Irrigation
Sejong Medical Co., Ltd., KR
HET
Mar 21, 2017K163320LAP-Pump PP110
W.O.M. World of Medicine GmbH, DE
HET
Nov 20, 2015K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
KARL STORZ Endoscopy-America, Inc.
HET
Oct 1, 2015K151011VISERA 4K UHD SYSTEM
Olympus Medical Systems Corp., JP
HET
Sep 27, 2013K131656MORCELLEX SIGMA GENERATOR
ETHICON, Inc.
HET
Mar 1, 2013K123365OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
Olympus Medical Systems Corp.
HET
Apr 20, 2012K111425OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
Olympus Medical Systems Corp.
HET
Jan 13, 2012K111788ENDOEYE HD II
Olympus America, Inc.
HET
Mar 11, 2011K101458LINA XCISE MODEL MOR-1515
Lina Medical Aps
HET
Mar 1, 2011K091010TROKAMED MORCELLATOR
Trokamed GmbH, NL
HET
Mar 24, 2010K100280GYNCARE MORCELLEX TISSUE MORCELLATOR
ETHICON, Inc.
HET
Jun 29, 2009K080365MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
NOUVAG AG, CH
HET
Dec 23, 2008K081173ENDOSCOPIC CO2 REGULATION UNIT UCR
Olympus Medical Systems Corporation
HET
Dec 16, 2008K082451STRYKER VIDEOSCOPE
Stryker Endoscopy
HET
Sep 26, 2008K080948HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
Olympus Medical Systems Corporation
HET
Oct 13, 2006K062097VERESS CANNULA AND MODULAR VERESS CANNULA
PAJUNK GmbH Medizintechnologie, DE
HET
Aug 24, 2006K062169APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
Applied Medical Resources Corp.
HET
Jul 31, 2006K061268G-LIX TISSUE GRASPER
Usgi Medical
HET
Jul 14, 2006K061050GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
ETHICON, Inc.
HET
Apr 21, 2005K050404INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
Intuitive Surgical, Inc.
HET
Mar 4, 2005K043013MILTEX LAPAROSCOPIC INSTRUMENTS
Miltex, Inc.
HET
Jul 9, 2004K041321VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
Richard Wolf Medical Instruments Corp.
HET
Mar 12, 2004K040295APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
Applied Medical Resources Corp.
HET
Mar 11, 2004K033177POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
Gunter Bissinger Medizintechnik GmbH, NL
HET
Apr 10, 2003K021237COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
CooperSurgical, Inc., DE
HET
Oct 18, 2002K022384XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
Isolux America
HET
Oct 9, 2002K022748REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
Medical Device Services
HET
Feb 20, 2002K020143VASOVIEW 5 HARVESTING CANNULA
Guidant Corporation, Cardiac Surgery
HET
Jul 22, 2001K003805GYNECOLOGICAL LAPAROSCOPES
Global Endoscopy, Inc.
HET
May 16, 2001K010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
A & A Medical, Inc.
HET
Apr 4, 2001K003417MINI FIBER ENDOSCOPES; OUTER SHEATHS; VERESS CANNULAS; VERESS CANNULAS WITH OUTER SHEATHS, SET
Richard Wolf Medical Instruments Corp.
HET
Jan 8, 2001K003164TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM
Richard Wolf Medical Instruments Corp.
HET
Jun 9, 2000K993653MICRO-FRANCE TROCARS AND ACCESSORIES
Xomed, Inc.
HET
May 16, 2000K001220ENDOPATH SURESEAL REDUCER CAP
Ethicon Endo-Surgery, Inc.
HET
Apr 13, 2000K000199CORTEK MINI LAPAROSCOPE
Cortek Endoscopy, Inc.
HET
Mar 17, 2000K992513THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HET
Mar 17, 2000K992481CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HET
Feb 7, 2000K993801GYNECARE LAPAROSCOPIC MORCELLATOR
ETHICON, Inc.
HET

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