Last synced on 25 January 2026 at 3:41 am

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K252043
510(k) Type
Traditional
Applicant
Olympus Winter &Ibe GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
9/23/2025
Days to Decision
85 days
Submission Type
Summary

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K252043
510(k) Type
Traditional
Applicant
Olympus Winter &Ibe GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
9/23/2025
Days to Decision
85 days
Submission Type
Summary