HET · Laparoscope, Gynecologic (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.1720 · Class 2
Overview
| Product Code | HET |
|---|---|
| Device Name | Laparoscope, Gynecologic (And Accessories) |
| Regulation | 21 CFR 884.1720 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Classification Rationale
(1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources.
Recent Cleared Devices (20 of 338)
Showing 20 most recent of 338 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | Aug 29, 2025 | SESE |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | Apr 25, 2025 | SESE |
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | Dec 12, 2022 | SESE |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Oct 13, 2021 | SESE |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | Sep 17, 2021 | SESE |
| K210104 | SurroundScope System | 270surgical , Ltd. | Jul 8, 2021 | SESE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | Mar 12, 2021 | SESE |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | Aug 21, 2020 | SESE |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | Apr 3, 2020 | SESE |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | Nov 1, 2019 | SESE |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | Aug 29, 2019 | SESE |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | Jan 18, 2018 | SESE |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | Nov 28, 2017 | SESE |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | Mar 21, 2017 | SESE |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | Nov 20, 2015 | SESE |
| K151011 | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | Oct 1, 2015 | SESE |
| K131656 | MORCELLEX SIGMA GENERATOR | ETHICON, Inc. | Sep 27, 2013 | SESE |
| K123365 | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | Olympus Medical Systems Corp. | Mar 1, 2013 | SESE |
| K111425 | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | Olympus Medical Systems Corp. | Apr 20, 2012 | SESE |
| K111788 | ENDOEYE HD II | Olympus America, Inc. | Jan 13, 2012 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 29 clearances
- Dixon Medical, Inc. — 12 clearances
- ETHICON, Inc. — 11 clearances
- Marlo Surgical Technology — 10 clearances
- Baxter Healthcare Corp — 9 clearances
