FDA.report

510(k) K240098

Device
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
Applicant
STERIS Corporation
510(k) number
K240098
Product code
ODC
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-09
Date received
2024-01-12
Regulation
876.1500
Classification name
Endoscope Channel Accessory
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Jackie Oliver
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers

Source Documents

510(k) summary PDF

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