510(k) K193018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Surgical Direct Hand-held Laparoscopic Instruments
| Applicant | Surgical Direct, Inc., Deland FL, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Oct 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193018
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.