510(k) K080161
- Device
- PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
- Applicant
- PATTON SURGICAL CORP.
- 510(k) number
- K080161
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-29
- Date received
- 2008-01-23
- 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
- MICHAEL PATTON
- Address
- 6300 Bridgepoint Pkwy. Bldg. 2, Suite 420 Austin TX US 78730 78730
FDA Registration Numbers#
- 3031238646
- 1221934
- 3005528784
- 9515015
- 1450997
- 3010305275
- 3005465238
- 9611274
- 9710649
- 1320468
- 2245304
- 3005110411
- 3008843439
- 1047843
- 3005595283
- 3010432890
- 3012329552
- 9611112
- 2954921
- 3045813414
- 2529846
- 3007593944
- 3006498370
- 3007738736
- 1923569
- 8010510
- 2650143
- 3009039068
- 2649614
- 3001722928
- 9610612
- 3024137003
- 3007421149
- 3011230048
- 3004598644
- 3044828322
- 3016112537
- 3010291427
- 1000181154
- 3005075853
- 3011137372
- 3015231789
- 1055236
- 3003687489
- 3003407244
- 3021336182
- 3015453963
- 3010701807
- 3016804805
- 3010590422
- 3009380063
- 3030447506
- 3008044552
- 3009881188
- 1643264
- 3002808148
- 8043903
- 1000121056
- 3010399422
- 3005699784
- 2647580
- 3002259632
- 1223422
- 3012507533
- 8043971
- 1220351
- 2032098
- 3013184361
- 9610773
- 9616088
- 3003790304
- 8010935
- 3004215117
- 1018233
- 3015241782
- 1720747
- 1054241
- 1226146
- 3020704423
Source Documents#
Other 510(k) Records For Product Code GCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., 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 |
Legacy Summary#
summary
FDA Review#
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