510(k) K193161 ยท GCJ Laparoscope, General & Plastic Surgery
Pristine Scope
| Applicant | Pristine Surgical, Manchester NH, US |
| Decision | Substantially Equivalent, Apr 21, 2020 |
| Received | Nov 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193161
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.