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FDA 510(k)

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

K-Number: K231889 · 2023-12-21

ApplicantUltrasound Biotechnology (Shanghai) Co., Ltd.
Decision Date2023-12-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is a medical device manufactured by Ultrasound Biotechnology (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under approval number K231889. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)?

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Ultrasound Biotechnology (Shanghai) Co., Ltd.. The 510(k) number is K231889.

When was Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) approved by the FDA?

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) received FDA 510(k) clearance on 2023-12-21, under approval number K231889.

What company makes Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)?

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is manufactured by Ultrasound Biotechnology (Shanghai) Co., Ltd..

What is the FDA product code for Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)?

The FDA product code for Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is IYO.

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Related PubMed Literature

PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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