510(k) K951343 ยท HET Laparoscope, Gynecologic (And Accessories)
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Apr 11, 1996 |
| Received | Mar 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2024 | Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE Open, Classified |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.