Clearance Summary
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller received FDA 510(k) clearance under submission number K251170, sponsored by Tangent Endoscopy, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-09-12.
- Submission: K251170
- Applicant / Sponsor: Tangent Endoscopy, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2025-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FBN and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.