510(k) K921716 ยท HET Laparoscope, Gynecologic (And Accessories)
DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
| Applicant | American Surgical Instruments Corp., Delray Beach FL, US |
| Decision | Substantially Equivalent, Nov 8, 1993 |
| Received | Apr 9, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921716
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.