Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)— 510(k) K231889

Name: FDA 510(k) clearance K231889
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Substantially Equivalent

Ultrasound Biotechnology (Shanghai) Co., Ltd.

FDA 510(k) clearance K231889 for Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS), Substantially Equivalent on 2023-12-21. Applicant: Ultrasound Biotechnology (Shanghai) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ultrasound Biotechnology (Shanghai) Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2023-06-27
Decision date: 2023-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.