K252043
- 510(k) number
- K252043
- Device name
- Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
- Applicant
- Olympus Winter & Ibe GmbH DE
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-09-23
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252043.pdf
Official FDA record: K252043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.