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FDA 510(k), K211347, Uretero1 Ureteroscope System
FDA 510(k), K211347, Uretero1 Ureteroscope System
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510(K) Number: K211347
Device Name: Uretero1 Ureteroscope System
Manufacturer: STERIS Corporation
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 05/03/2021
Decision Date: 11/23/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Uretero1 Ureteroscope System
Manufacturer: STERIS Corporation
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 05/03/2021
Decision Date: 11/23/2021
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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