HET — Laparoscope, Gynecologic (And Accessories) Class II
FDA Device Classification
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) | August 29, 2025 |
| K243821 | a.m.i. agency for medical innovations | i-Cut | April 25, 2025 |
| K221642 | precision robotics (hong kong) limited | SIRIUS Endoscope System | December 12, 2022 |
| K210116 | surgnova healthcare technologies (zhejiang) co | Video Endoscopy System, 3D Video Endoscopy System | October 13, 2021 |
| K201832 | olympus medical systems | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | September 17, 2021 |
| K210104 | 270surgical | SurroundScope System | July 8, 2021 |
| K201617 | schoelly fiberoptic | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera | March 12, 2021 |
| K200216 | scivita medical technology co | 4K UHD Camera System | August 21, 2020 |
| K200638 | sejong medical co | LAP-iX Suction Irrigation | April 3, 2020 |
| K190190 | 270surgical | WV1 Endoscope | November 1, 2019 |
| K190744 | olympus winter and ibe | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | August 29, 2019 |
| K172796 | medrobotics corporation | Flex Robotic System and Flex Transabdominal Drive | January 18, 2018 |
| K173111 | sejong medical co | LAP-iX Suction Irrigation | November 28, 2017 |
| K163320 | w.o.m. world of medicine | LAP-Pump PP110 | March 21, 2017 |
| K150525 | karl storz endoscopy-america | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | November 20, 2015 |
| K151011 | olympus medical systems | VISERA 4K UHD SYSTEM | October 1, 2015 |
| K131656 | ethicon | MORCELLEX SIGMA GENERATOR | September 27, 2013 |
| K123365 | olympus medical systems | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 | March 1, 2013 |
| K111425 | olympus medical systems | OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190 | April 20, 2012 |
| K111788 | olympus america | ENDOEYE HD II | January 13, 2012 |