OTU Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet, WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System, WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - OTU Medical, Inc. Gastroenterology & Urology ✕
4 devices
Cleared
Sep 29, 2023
WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible...
Gastroenterology & Urology
109d
Cleared
Apr 13, 2022
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible...
Gastroenterology & Urology
273d
Cleared
Jul 22, 2021
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible...
Gastroenterology & Urology
146d
Cleared
Aug 14, 2018
WiScope Digital Endoscope System
Gastroenterology & Urology
21d