510(k) K950976 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Mar 21, 1995 |
| Received | Mar 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A Open, Classified |
FBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.