510(k) K191438 ยท OCX Endoscopic Irrigation/Suction System
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
| Applicant | Erbe USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Jun 27, 2019 |
| Received | May 30, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191438
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.