510(k) K190469 ยท OCX Endoscopic Irrigation/Suction System
ERBEFLO 2 Disposable Tubing System
| Applicant | Erbe USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, May 23, 2019 |
| Received | Feb 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Erbe Medical, LLC ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 Open, Classified |
OCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.