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 |
|---|---|---|---|
| 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 |
| K252442 | applied medical resources | Kii Structural Balloon Access System | October 31, 2025 |
| K252697 | guangdong optomedic technologies | 3D Laparoscope | October 29, 2025 |
| K252640 | freyja healthcare | VereSee Optical Veres Needle and Endoscopic Camera | October 20, 2025 |
| K251994 | arthrex | Arthrex Synergy Vision Imaging System | October 16, 2025 |
| K243968 | revolve surgical | Revolve Surgical System | October 3, 2025 |
| K250551 | shenzhen sophway technology co | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | October 2, 2025 |
| K251743 | surgical principals | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | September 22, 2025 |
| K250130 | hangzhou viction medical technology co | Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA | August 6, 2025 |
| K250124 | hangzhou viction medical technology co | Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-I | August 6, 2025 |
| K252010 | stryker endoscopy | SPY Laparoscope | July 24, 2025 |
| K250820 | sinolinks medical innovation | Disposable Trocars | July 11, 2025 |