510(k) K260197 · GCJ Laparoscope, General & Plastic Surgery
Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
| Applicant | Suzhou Shenyun Medical Equipment Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Apr 8, 2026 |
| Received | Jan 22, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260197
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.