FDA 510(k)

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

Numéro K : K251170 · 2025-09-12

Date de décision2025-09-12

Code produitFBN

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : FBN)

K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.K253139Disposable Distal CapMirco-Tech (Nanjing) Co., Ltd.K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)Scivita Medical Technology Co., Ltd.K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)Shanghai SeeGen Photoelectric Technology Co., Ltd.K241444Biliary Pancreaticobiliary Scope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.K233752Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel CapsCenterPoint Systems, LLC

Source officielle

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