510(k) K221177 ยท OCX Endoscopic Irrigation/Suction System
Erbe's Tubing/Cap Sets
| Applicant | Erbe USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Aug 11, 2022 |
| Received | Apr 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Erbe Medical, LLC ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203; Open, Classified |
OCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.