FDA 510(k) ClearanceGCJ
Arthrex Synergy Vision Endoscopic Imaging System
FDA 510(k) K241361 · Arthrex, Inc.
- 510(k) number
- K241361
- Device name
- Arthrex Synergy Vision Endoscopic Imaging System
- Applicant
- Arthrex, Inc.
- Product code
- GCJ
- Decision
- Substantially Equivalent
- Decision date
- 2024-07-25
- Device class
- Class 2
- Regulation number
- 876.1500
- Advisory committee
- Gastroenterology, Urology
- Medical specialty
- Gastroenterology, Urology
Candidate predicate devices
Other devices cleared under product code GCJ — the same regulatory device type, and therefore candidate predicates for a substantial-equivalence comparison. Confirm each predicate is legally marketed before relying on it.
| 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 |
| 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 |
Building a 510(k) around this device type?
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