Medical Device Manufacturer · US , Winston Salem , NC

Uro-1, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Uro-1, Inc. Gastroenterology & Urology ✕
2 devices
1-2 of 2
Cleared Jan 15, 2021
VMCore Biopsy Needle
K201650 · KNW
Gastroenterology & Urology · 211d
Cleared May 03, 2018
Repris Bladder Injection System
K180214 · FBK
Gastroenterology & Urology · 98d
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All3 Gastroenterology & Urology 2 General & Plastic Surgery 1