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FDA 510(k)

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

K-Number: K233752 · 2024-05-02

ApplicantCenterPoint Systems, LLC
Decision Date2024-05-02
Product CodeFBN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

When was Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps approved by the FDA?

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

What company makes Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps?

Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps is manufactured by CenterPoint Systems, LLC.

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.

Related PubMed Literature

PMID: 40206521 Embedding Internal Accountability Into Health Care Institutions for Safe, Effective, and Ethical Implementation of Artificial Intelligence Into Medical Practice: A Mayo Clinic Case Study. Mayo Clinic proceedings. Digital health (2024)

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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.

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