FDA 510(k)

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps

Numéro K : K233752 · 2024-05-02

Date de décision2024-05-02

Code produitFBN

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is the device name listed in this FDA 510(k) record. The listed applicant is CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K233752. 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 Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is CenterPoint Systems, LLC. The 510(k) number is K233752.

When did Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps receive FDA 510(k) clearance?

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps received FDA 510(k) clearance on 2024-05-02, under 510(k) number K233752.

Who is the listed applicant for Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

The FDA 510(k) record lists CenterPoint Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

The FDA product code for Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is FBN.

Essais cliniques associés

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Dispositifs connexes (Code : FBN)

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Source officielle

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