Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

K251170 is the FDA 510(k) clearance record for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller, a class II device, cleared for Tangent Endoscopy, LLC on 2025-09-12 under FDA product code FBN (Choledochoscope And Accessories, Flexible/Rigid). FDA's definition for product code FBN reads: "to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list one 510(k) clearance for Tangent Endoscopy, LLC. As of 2026-09-10, FDA records show one recall naming K251170.