510(k) K240098

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) by STERIS Corporation — Product Code ODC

K240098 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)". The FDA issued a decision of Substantially Equivalent on February 9, 2024. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500. STERIS Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2024
Date Received
January 12, 2024
Clearance Type
Special
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

To give the endoscope channel additional or improved functionality.