Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)— 510(k) K252043

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K252043 for Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211), Substantially Equivalent on 2025-09-23. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-06-30
Decision date: 2025-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.