# K251170: Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

- Pathway: 510(k) (Traditional)
- Applicant: Tangent Endoscopy, LLC
- Decided: Sep 12, 2025 after 150 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K220743: CediTEC, Voco GmbH (2022). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Mar 23, 2026 · Class II · Z-2209-2026: Affected devices exhibited fractures at the distal shaft tip without complete detachment.

## Indications for use
The Tangent Single-Use Digital System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Tangent Single-Use Digital System comprises two components: the Tangent Single-Use Digital Catheter and the Tangent Digital Controller. The Tangent Single-Use Digital Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Tangent Digital Controller is intended to provide illumination and receive, process, and output images from the Tangent Single-Use Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K251170
Methodology: https://510kreport.com/methodology