K250145
- 510(k) number
- K250145
- Device name
- Biopsy Port Adapter
- Applicant
- Endosound, Inc. OR · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2025-10-17
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250145.pdf
Official FDA record: K250145
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.