K251140
- 510(k) number
- K251140
- Device name
- Zenflow Spring Scope
- Applicant
- Zenflow, Inc. CA · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-09-23
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251140.pdf
Official FDA record: K251140
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.