510(k) K172618 ยท GCJ Laparoscope, General & Plastic Surgery
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Dec 5, 2017 |
| Received | Aug 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172618
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.