510(k) K951190 ยท HET Laparoscope, Gynecologic (And Accessories)
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Jun 14, 1995 |
| Received | Mar 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2023 | Karl Storz Endoscopy Injection Needle, LUER-lock,0.8mm, REF: 26175PD Open, Classified |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.