510(k) K202104
K202104 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "BioGuard EUS Air/Water and Suction Valves". The FDA issued a decision of Substantially Equivalent on Jan 14, 2021. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. STERIS Corporation has 204 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 2021
- Date Received
- Jul 29, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To give the endoscope channel additional or improved functionality.