Name: Predicase
Price: 199 USD

K-number	K233752
Device name	Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps
Applicant	CenterPoint Systems, LLC
Product code	FBN
Device class	Class II
Decision date	May 2, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.

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