K-number	K220611
Device name	SUREcore Plus Biopsy Instrument
Applicant	Uro-1, Inc.
Product code	KNW
Device class	Class II
Decision date	Dec 2, 2022
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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SUREcore Plus Biopsy Instrument

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