510(k) K163654
- Device
- VersaOne Fascial Closure System Bladed Trocar, VersaOne Fascial Closure System Bladeless Trocar, VersaOne Fascial Closure System Optical Trocar
- Applicant
- Covidien Llc
- 510(k) number
- K163654
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-08
- Date received
- 2016-12-23
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gary LeMere
- Address
- 60 Middletown Ave. North Haven CT US 06473 06473
FDA Registration Numbers#
- 1221934
- 3013176080
- 9680952
- 3009380063
- 3020142503
- 3009881188
- 2431166
- 2029275
- 3004111573
- 2134944
- 9611274
- 3018984
- 3013283620
- 3004122598
- 3015612252
- 3004378299
- 3012322232
- 1836161
- 1225984
- 2032098
- 3006581049
- 2434982
- 9614969
- 3010043098
- 9613846
- 3000237660
- 9610595
- 3009420598
- 2434839
- 8030607
- 9611827
- 3021744379
- 1037955
- 8043746
- 3018126215
- 3014479313
- 3010547268
- 3014273609
- 3013944123
- 3009134855
- 3010703925
- 3030839824
- 3012818475
- 3015542154
- 2124215
- 3048246462
- 8040233
- 3016832577
- 2242352
- 1061124
- 8010591
- 3012507533
- 3005809810
- 3022626486
- 2529846
- 1320894
- 2648727
- 3030153385
- 9710058
- 3011416394
- 3014461810
- 1055236
- 3010684280
- 9611612
- 8010935
- 1221826
- 3010380518
- 1222997
- 3020704423
- 3020331900
- 3032391
- 3004644065
- 3016112537
- 8022210
- 3006554912
- 3013184361
- 3013557562
- 9611102
- 3010860245
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262397 | CuratOR EX2742 | Eizo Corporation | 2026-09-11 |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026-09-01 |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | 2026-08-26 |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | 2026-08-13 |
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) | Medical Impact | 2026-07-24 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. | 2026-06-11 |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 |
Legacy Summary#
summary
FDA Review#
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