K253505
- 510(k) number
- K253505
- Device name
- Zamenix P
- Applicant
- Roen Surgical, Inc. KR
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-08-07
- Date received
- 2025-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253505.pdf
Official FDA record: K253505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.