FDA.reportPublic FDA data

510(k) K220884

Device
Disposable Endoscope Valve Sets
Applicant
Sml Med-Tech Solutions Limited
510(k) number
K220884
Product code
ODC
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-17
Date received
2022-03-28
Regulation
876.1500
Classification name
Endoscope Channel Accessory
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark Ko
Address
Rm.406, Wah Yiu Indl Ctr, 30-32 Au Pui Wan St. Fo Tan, N.T. CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K232327EndorailEndostart S.R.L.2024-03-15
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K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation2024-03-06
K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation2024-02-09