510(k) K902657
- Device
- GYNESCOPE LAPAROSCOPIC FORCEPS
- Applicant
- GYNESCOPE CORP.
- 510(k) number
- K902657
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-19
- Date received
- 1990-06-15
- Regulation
- 884.1720
- Classification name
- Laparoscope, Gynecologic (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT C MARLOW
- Address
- 1810 Joseph Lloyd Pkwy. Willoughby OH US 44094 44094
FDA Registration Numbers#
- 3010155661
- 3009217531
- 3013023969
- 1423662
- 1211566
- 3002807315
- 3033043422
- 2030598
- 3005049530
- 9615001
- 3006787036
- 3015540957
- 1836161
- 1643264
- 9611503
- 1320894
- 3001556604
- 1418479
- 1035968
- 2434839
- 3008386005
- 3009051888
- 3019807891
- 9680718
- 8010047
- 8010510
- 3008571754
- 8010298
- 1221826
- 1058584
- 9680721
- 3004111573
- 3004644065
- 3006546082
- 3004447686
- 8043746
- 3009420598
- 1923569
- 3011050570
- 3031240334
- 3007421149
- 3021839632
- 3009134855
- 2020550
- 1319639
- 1820334
- 8010418
- 3009380063
- 1825146
- 3014342096
- 9611612
- 3008439467
- 8010487
- 3008837339
- 9610612
- 8030607
- 9612278
- 9610617
- 1412854
- 1219602
- 3013011598
- 3012460907
- 1017294
- 3009763019
- 2647580
- 3008494403
- 3024021261
- 9680515
- 2027009
- 3002808148
- 3015976667
- 3029968414
- 3007789561
- 9610773
- 3014615697
- 3014334038
- 1219930
- 9614969
- 1057358
- 3006897899
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HET #
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases