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FDA 510(k)

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

K-Number: K251170 · 2025-09-12

ApplicantTangent Endoscopy, LLC
Decision Date2025-09-12
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller is a medical device manufactured by Tangent Endoscopy, LLC. It received FDA 510(k) clearance on 2025-09-12 under approval number K251170. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by Tangent Endoscopy, LLC. The 510(k) number is K251170.

When was Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller approved by the FDA?

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller received FDA 510(k) clearance on 2025-09-12, under approval number K251170.

What company makes 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 manufactured by Tangent Endoscopy, LLC.

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.

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Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Related Devices (Code: FBN)

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Official Source

View on FDA Database →

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