510(k) K253598 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
InjecSURE Injection System
| Applicant | Carbon Medical Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 31, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253598
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.