FDA 510(k) clearance · back to tracker

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

Tangent Endoscopy, LLC cleared K251170 on 2025-09-12, decision: substantially equivalent

K-number

K251170

Sponsor

Tangent Endoscopy, LLC

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-09-12

Product code

FBN

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1500

Official FDA record

Open K251170on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.