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 |
|---|---|---|---|
| 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 |
| K260185 | stryker endoscopy | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with | February 18, 2026 |
| K260177 | xenocor | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | February 12, 2026 |
| K251923 | hangzhou hawk optical electronic instruments co | Medical Shaver System (Morcellator) (YSB-IIIA) | January 29, 2026 |
| K252957 | ab medica | Pneumo Dissector Hook | January 23, 2026 |
| K254014 | stryker endoscopy | Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys | January 13, 2026 |