510(k) K926596
- Device
- OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
- Applicant
- OWENS INDUSTRIES, INC.
- 510(k) number
- K926596
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-06-10
- Date received
- 1992-09-09
- 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
- TERRENCE R SHORE
- Address
- 7815 S. 6th St. Oak Creek WI US 53154 53154
FDA Registration Numbers#
- 3006787036
- 3024785124
- 9610612
- 3018094310
- 3013247477
- 3008044552
- 3007699067
- 1720747
- 3013011598
- 8010047
- 3008837339
- 3007156625
- 1057358
- 8010298
- 3012322232
- 3019807891
- 3021839632
- 2244478
- 3010707607
- 9610773
- 1418479
- 1061124
- 9612074
- 1055236
- 3015219237
- 3001556604
- 3009756153
- 3004111573
- 3002808148
- 2030598
- 8043746
- 9611612
- 1483278
- 2936485
- 9614434
- 9611503
- 1320894
- 3011986317
- 2434839
- 3024021261
- 1221826
- 3007789561
- 9612501
- 1423714
- 3011050570
- 3008595179
- 9680718
- 9610617
- 3010155661
- 1017294
- 3009039068
- 1018470
- 8040510
- 2248148
- 1820334
- 9614969
- 2027111
- 3010202439
- 8010877
- 8043903
- 1058584
- 3009420598
- 8010487
- 3004361445
- 8044098
- 3008132398
- 3002807315
- 3014615697
- 8010510
- 3009051888
- 9610595
- 1319639
- 3012507533
- 3027454635
- 1216677
- 3015976667
- 2032521
- 3005049530
- 3009134855
- 1519132
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#
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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