Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
K-Number: K251170 · 2025-09-12
Device Summary
Frequently Asked Questions
What is the Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Tangent Endoscopy, LLC. The 510(k) number is K251170.
When did Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller receive FDA 510(k) clearance?
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller received FDA 510(k) clearance on 2025-09-12, under 510(k) number K251170.
Who is the listed applicant for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?
The FDA 510(k) record lists Tangent Endoscopy, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller?
The FDA product code for Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller is FBN.
Related Devices (Code: FBN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.