Urocross Expander System (Model Numbers ES2018 and ES3025)— 510(k) K253525
Substantially EquivalentProdeon Medical, Inc.
FDA 510(k) clearance K253525 for Urocross Expander System (Model Numbers ES2018 and ES3025), Substantially Equivalent on 2026-03-12. Applicant: Prodeon Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Prodeon Medical, Inc.
- Product code
- Code QKA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5510
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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