510(k) K971836
- Device
- VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
- Applicant
- COOPERSURGICAL, INC.
- 510(k) number
- K971836
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-07
- Date received
- 1997-05-19
- Regulation
- 884.1720
- Classification name
- Laparoscope, Gynecologic (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBRA A PEKAR
- Address
- 15 Forest Pkwy. Shelton CT US 06484 06484
FDA Registration Numbers#
- 3024021261
- 1218882
- 2029275
- 9610612
- 1519132
- 2244478
- 9680837
- 3008494403
- 3014334038
- 1216677
- 1211566
- 2248148
- 1423662
- 8043746
- 3009057691
- 3007421149
- 2649614
- 2648623
- 8010047
- 8044098
- 3011050570
- 3011986317
- 3010202439
- 2936485
- 2032521
- 3018094310
- 1319639
- 3004608878
- 1054241
- 2647580
- 3003724334
- 3007699067
- 1018470
- 3017636737
- 8010487
- 3009134855
- 9611102
- 1219930
- 3004361445
- 3019783123
- 1923569
- 3005049530
- 1035968
- 9614969
- 1423714
- 9614434
- 3003790304
- 9610773
- 1221826
- 9611503
- 1055236
- 3025482817
- 3008386005
- 1720747
- 3004111573
- 3029968414
- 3013023969
- 1825146
- 3009380063
- 8030607
- 8040510
- 3015972753
- 1649518
- 2020550
- 3002808148
- 1820334
- 3009763019
- 8010418
- 1061124
- 9610595
- 1017294
- 2027009
- 3002807315
- 3007789561
- 3006546082
- 3003418325
- 3013011598
- 3012460907
- 1836161
- 2320762
Source Documents#
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#
summary
FDA Review#
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