K250118
- 510(k) number
- K250118
- Device name
- Disposable Balloon Catheter B5-2C
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2025-06-04
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K250118.pdf
Official FDA record: K250118
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.