K252572
- 510(k) number
- K252572
- Device name
- Prodeon Urethral Sheath System
- Applicant
- Prodeon Medical, Inc. CA · US
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2025-10-07
- Date received
- 2025-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252572.pdf
Official FDA record: K252572
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.