K251170
- 510(k) number
- K251170
- Device name
- Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
- Applicant
- Tangent Endoscopy, LLC DE · US
- Product code
- FBN — Choledochoscope And Accessories, Flexible/Rigid
- Decision date
- 2025-09-12
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251170.pdf
Official FDA record: K251170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.