GCJ — Laparoscope, General & Plastic Surgery Class II
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 |
|---|---|---|---|
| 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 |
| K250927 | karl storz se and co. kg | KARL STORZ Cholangiography Set | November 22, 2025 |
| K242606 | integrated endoscopy | Nuvis® Wireless HD Camera System (Nuvis-2K) | November 20, 2025 |