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FDA 510(k) Applications Submitted by Uro-1, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180214
01/25/2018
Repris Bladder Injection System
URO-1, Inc.
K220611
03/03/2022
SUREcore Plus Biopsy Instrument
Uro-1, Inc.
K201650
06/18/2020
VMCore Biopsy Needle
URO-1, Inc.
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