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FDA 510(k)

Disposable Endoscopy Valve Set

K-Number: K250732 · 2025-06-20

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2025-06-20
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopy Valve Set is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250732. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endoscopy Valve Set?

Disposable Endoscopy Valve Set is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K250732.

When did Disposable Endoscopy Valve Set receive FDA 510(k) clearance?

Disposable Endoscopy Valve Set received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250732.

Who is the listed applicant for Disposable Endoscopy Valve Set?

The FDA 510(k) record lists Yangzhou Fartley Medical Instrument Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopy Valve Set?

The FDA product code for Disposable Endoscopy Valve Set is ODC.

Other records listing Yangzhou Fartley Medical Instrument Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ODC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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