Name: Predicase
Price: 199 USD

K-number	K222865
Device name	M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
Applicant	Canyon Medical, Inc.
Product code	KNW
Device class	Class II
Decision date	Apr 3, 2023
Decision	Substantially Equivalent
Regulation	876.1075

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

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