Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller— 510(k) K251170

Substantially Equivalent

Tangent Endoscopy, LLC

FDA 510(k) clearance K251170 for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller, Substantially Equivalent on 2025-09-12. Applicant: Tangent Endoscopy, LLC.

Clearance details

Applicant: Tangent Endoscopy, LLC
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-15
Decision date: 2025-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camden, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.