FDA 510(k), K202104, BioGuard EUS Air/Water and Suction Valves
FDA 510(k), K202104, BioGuard EUS Air/Water and Suction Valves
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510(K) Number: K202104
Device Name: BioGuard EUS Air/Water and Suction Valves
Manufacturer: Steris Corporation
Device Classification Name: Endoscope Channel Accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 07/29/2020
Decision Date: 01/14/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: BioGuard EUS Air/Water and Suction Valves
Manufacturer: Steris Corporation
Device Classification Name: Endoscope Channel Accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 07/29/2020
Decision Date: 01/14/2021
Regulation Medical Specialty: Gastroenterology/Urology
- 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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