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#
- 3004044817
- 3014279513
- 3010547268
- 1000181154
- 3015806723
- 3015532525
- 1526534
- 9680721
- 8044098
- 2320767
- 3005809810
- 3010380518
- 3030626857
- 9614209
- 3010419931
- 8043746
- 3010202439
- 3007305485
- 8010047
- 1123137
- 9611612
- 9611112
- 3014579161
- 3008114965
- 3010155648
- 9610617
- 3014262693
- 8010935
- 3016851379
- 3010160527
- 3014202166
- 1054811
- 2135348
- 3003435550
- 1221826
- 3009328501
- 3015335150
- 3017196117
- 3008386005
- 1226146
- 1060680
- 3030926959
- 3003542872
- 3043226252
- 3013011598
- 3007303113
- 1018233
- 9681129
- 9710058
- 3010432890
- 3011782009
- 3007345416
- 3007111496
- 2518897
- 3002907620
- 3031594238
- 2124215
- 9612075
- 3004142400
- 3004091527
- 3015539532
- 1055236
- 3023852420
- 1650907
- 2134944
- 3032391
- 9610595
- 3017636737
- 3002579136
- 3005441393
- 3009039068
- 1216677
- 3012494290
- 2523676
- 9611594
- 3021140368
- 3027339877
- 3012460907
- 3022626486
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-02-24 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2026-02-18 |
| K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | 2026-02-12 |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 2026-01-23 |
Legacy Summary#
summary
FDA Review#
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