GCJ — Laparoscope, General & Plastic Surgery Class II
FDA product code GCJ covers "Laparoscope, General & Plastic Surgery", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCJ
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262397 | eizo corporation | CuratOR EX2742 | September 11, 2026 |
| K260884 | karl storz se and co. kg | UNIDRIVE Select System | September 1, 2026 |
| K260972 | sony corporation | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | August 26, 2026 |
| K261139 | freyja healthcare | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | August 13, 2026 |
| K253541 | medical impact | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Dev | July 24, 2026 |
| K261614 | lg electronics | LED LCD Monitor (OEV-271H) | July 17, 2026 |
| K261249 | intuitive surgical | Universal Seal (5-12 mm) | July 14, 2026 |
| K260710 | floshield | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T | June 11, 2026 |
| K260414 | tech-image co | Tech-Image Video Endoscope System | June 10, 2026 |
| K253994 | trocare | TroKit Laparoscope Lens Wiper | June 4, 2026 |
| K252532 | taiwan surgical corporation | Inno-Port Disposable Bladed Trocar | June 2, 2026 |
| K260318 | zhejiang healnoc technology co | 4K NIR/ICG Imaging System | May 26, 2026 |
| K260183 | parallel robotics | MediBot Needle Driver Uno | May 24, 2026 |
| K252985 | sejong medical co | Laport | May 19, 2026 |
| K254228 | karl storz se and co. kg | KARL STORZ Trocars with Valve Seals | May 11, 2026 |
| K252858 | kms medical technology co | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | April 30, 2026 |
| K260089 | scopix | TL-10 Laparoscopic Scope Cleaner | April 8, 2026 |
| K260197 | suzhou shenyun medical equipment co | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | April 8, 2026 |
| K252714 | vigor medical technologies | C-Lant Port | February 27, 2026 |
| K253978 | intuitive surgical | Universal Seal (5-12 mm) | February 24, 2026 |