HET — Laparoscope, Gynecologic (And Accessories) Class II
FDA product code HET covers "Laparoscope, Gynecologic (And Accessories)", a Class II medical device regulated under 21 CFR 884.1720. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HET
- Device Class
- Class II
- Regulation Number
- 884.1720
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250939 | Precision Robotics (Hong Kong) Limited | SIRIUS Endoscope System (PR-SI-1230) | Aug 29, 2025 |
| K243821 | A.M.I. Agency For Medical Innovations | i-Cut | Apr 25, 2025 |
| K221642 | Precision Robotics (Hong Kong) Limited | SIRIUS Endoscope System | Dec 12, 2022 |
| K210116 | Surgnova Healthcare Technologies (Zhejiang) Co | Video Endoscopy System, 3D Video Endoscopy System | Oct 13, 2021 |
| K201832 | Olympus Medical Systems | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Sep 17, 2021 |
| K210104 | 270Surgical | SurroundScope System | Jul 8, 2021 |
| K201617 | Schoelly Fiberoptic | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera | Mar 12, 2021 |
| K200216 | Scivita Medical Technology Co | 4K UHD Camera System | Aug 21, 2020 |
| K200638 | Sejong Medical Co | LAP-iX Suction Irrigation | Apr 3, 2020 |
| K190190 | 270Surgical | WV1 Endoscope | Nov 1, 2019 |
| K190744 | Olympus Winter And Ibe | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Aug 29, 2019 |
| K172796 | Medrobotics Corporation | Flex Robotic System and Flex Transabdominal Drive | Jan 18, 2018 |
| K173111 | Sejong Medical Co | LAP-iX Suction Irrigation | Nov 28, 2017 |
| K163320 | W.O.M. World Of Medicine | LAP-Pump PP110 | Mar 21, 2017 |
| K150525 | Karl Storz Endoscopy-America | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | Nov 20, 2015 |
| K151011 | Olympus Medical Systems | VISERA 4K UHD SYSTEM | Oct 1, 2015 |
| K131656 | Ethicon | MORCELLEX SIGMA GENERATOR | Sep 27, 2013 |
| K123365 | Olympus Medical Systems | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | Mar 1, 2013 |
| K111425 | Olympus Medical Systems | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | Apr 20, 2012 |
| K111788 | Olympus America | ENDOEYE HD II | Jan 13, 2012 |