510(k) K252021 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Disposable Endoscopic Injection Needles
| Applicant | Changzhou New Med Micro-Medtech Co., Ltd., Changzhou, CN |
| Decision | Substantially Equivalent, Dec 2, 2025 |
| Received | Jun 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252021
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.