Product code HET
- Device name
- Laparoscope, Gynecologic (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1720
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | 2025-08-29 |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | 2022-12-12 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021-09-17 |
| K210104 | SurroundScope System | 270surgical , Ltd. | 2021-07-08 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | 2021-03-12 |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020-08-21 |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | 2019-11-01 |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019-08-29 |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | 2018-01-18 |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2017-11-28 |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | 2017-03-21 |
| 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 |
| K151011 | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | 2015-10-01 |
| K131656 | MORCELLEX SIGMA GENERATOR | ETHICON, Inc. | 2013-09-27 |
| K123365 | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | Olympus Medical Systems Corp. | 2013-03-01 |
| K111425 | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | Olympus Medical Systems Corp. | 2012-04-20 |
| K111788 | ENDOEYE HD II | Olympus America, Inc. | 2012-01-13 |
| K101458 | LINA XCISE MODEL MOR-1515 | Lina Medical Aps | 2011-03-11 |
| K091010 | TROKAMED MORCELLATOR | Trokamed GmbH | 2011-03-01 |
| K100280 | GYNCARE MORCELLEX TISSUE MORCELLATOR | ETHICON, Inc. | 2010-03-24 |
| K080365 | MORCE POWER PLUS AND VARIOCARVE MORCELLATOR | NOUVAG AG | 2009-06-29 |
| K081173 | ENDOSCOPIC CO2 REGULATION UNIT UCR | Olympus Medical Systems Corporation | 2008-12-23 |
| K082451 | STRYKER VIDEOSCOPE | Stryker Endoscopy | 2008-12-16 |
| K080948 | HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH | Olympus Medical Systems Corporation | 2008-09-26 |
| K062097 | VERESS CANNULA AND MODULAR VERESS CANNULA | PAJUNK GmbH Medizintechnologie | 2006-10-13 |
| K062169 | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS | Applied Medical Resources Corp. | 2006-08-24 |
| K061268 | G-LIX TISSUE GRASPER | Usgi Medical | 2006-07-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780538660 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780538646 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780538622 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780538608 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| ENOU2090NOU0 | Electronic motor 21 | Nouvag AG | 2017-01-13 |
| ENOU1507NOU0 | Vario Foot control | Nouvag AG | 2017-01-13 |
| 07613327061659 | AHTO | STRYKER CORPORATION | 2016-09-23 |
| 07613327051469 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327061475 | AHTO | STRYKER CORPORATION | 2016-09-23 |
| 07613327061499 | AHTO | STRYKER CORPORATION | 2016-09-23 |
| 10381780089049 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780096566 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-21 |
| 10381780095040 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-20 |
| 10381780092438 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-20 |
| 10381780097433 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-20 |
| 10381780094920 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-20 |
| 07613327052138 | AHTO | STRYKER CORPORATION | 2016-08-22 |
| 10381780152156 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152163 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152170 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152187 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152194 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152200 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152217 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152224 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152231 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152828 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152835 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152842 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152149 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |