FDA applicant
Olympus Winter & Ibe GmbH
FDA records 43 decisions for Olympus Winter & Ibe GmbH (Hamburg, DE) from 1997 to 2026: 43 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FAS (Electrode, Electrosurgical, Active, Urological). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 76 predicates, 17 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus Winter & Ibe GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Olympus Winter & Ibe GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Olympus”
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