Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1720](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1720) → HET — Laparoscope, Gynecologic (And Accessories) # HET · Laparoscope, Gynecologic (And Accessories) _Obstetrics/Gynecology · 21 CFR 884.1720 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET ## Overview - **Product Code:** HET - **Device Name:** Laparoscope, Gynecologic (And Accessories) - **Regulation:** [21 CFR 884.1720](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1720) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) ## 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](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K250939.md) | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | Aug 29, 2025 | SESE | | [K243821](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K243821.md) | i-Cut | A.M.I. Agency For Medical Innovations GmbH | Apr 25, 2025 | SESE | | [K221642](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K221642.md) | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | Dec 12, 2022 | SESE | | [K210116](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K210116.md) | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Oct 13, 2021 | SESE | | [K201832](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K201832.md) | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | Sep 17, 2021 | SESE | | [K210104](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K210104.md) | SurroundScope System | 270surgical , Ltd. | Jul 8, 2021 | SESE | | [K201617](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K201617.md) | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | Mar 12, 2021 | SESE | | [K200216](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K200216.md) | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | Aug 21, 2020 | SESE | | [K200638](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K200638.md) | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | Apr 3, 2020 | SESE | | [K190190](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K190190.md) | WV1 Endoscope | 270surgical , Ltd. | Nov 1, 2019 | SESE | | [K190744](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K190744.md) | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | Aug 29, 2019 | SESE | | [K172796](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K172796.md) | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | Jan 18, 2018 | SESE | | [K173111](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K173111.md) | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | Nov 28, 2017 | SESE | | [K163320](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K163320.md) | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | Mar 21, 2017 | SESE | | [K150525](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K150525.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K151011.md) | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | Oct 1, 2015 | SESE | | [K131656](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K131656.md) | MORCELLEX SIGMA GENERATOR | ETHICON, Inc. | Sep 27, 2013 | SESE | | [K123365](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K123365.md) | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | Olympus Medical Systems Corp. | Mar 1, 2013 | SESE | | [K111425](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K111425.md) | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | Olympus Medical Systems Corp. | Apr 20, 2012 | SESE | | [K111788](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K111788.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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