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FDA 510(k)

Pentax Medical Valve Set

K-Number: K222980 · 2022-11-21

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2022-11-21
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pentax Medical Valve Set is a medical device manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under approval number K222980. 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 Pentax Medical Valve Set?

Pentax Medical Valve Set is a medical device that received FDA 510(k) clearance on 2022-11-21. It is manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K222980.

When was Pentax Medical Valve Set approved by the FDA?

Pentax Medical Valve Set received FDA 510(k) clearance on 2022-11-21, under approval number K222980.

What company makes Pentax Medical Valve Set?

Pentax Medical Valve Set is manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd..

What is the FDA product code for Pentax Medical Valve Set?

The FDA product code for Pentax Medical Valve Set is ODC.

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Other Devices by Yangzhou Fartley Medical Instrument Technology Co., Ltd.

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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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