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510(k) K200769

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B by Wilson Instruments (Sha) Co., Ltd. — Product Code ODC

K200769 is an FDA 510(k) premarket notification submitted by Wilson Instruments (Sha) Co., Ltd. for the device "Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B". The FDA issued a decision of Substantially Equivalent on Jan 6, 2021. The device falls under product code ODC (Endoscope Channel Accessory), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 6, 2021
Date Received
Mar 25, 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.

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  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (Oct 11, 2024)
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FDA data resources