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510(k) K231889

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) by Ultrasound Biotechnology (Shanghai) Co., Ltd. — Product Code IYO

K231889 is an FDA 510(k) premarket notification submitted by Ultrasound Biotechnology (Shanghai) Co., Ltd. for the device "Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2023
Date Received
June 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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FDA data resources