510(k) K240098
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.