510(k) K250551 ยท GCJ Laparoscope, General & Plastic Surgery
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
| Applicant | Shenzhen Sophway Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Oct 2, 2025 |
| Received | Feb 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250551
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.