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FDA 510(k)

Sclerotherapy Needle

K-Number: K212668 · 2022-02-23

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2022-02-23
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Sclerotherapy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212668. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sclerotherapy Needle?

Sclerotherapy Needle is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K212668.

When did Sclerotherapy Needle receive FDA 510(k) clearance?

Sclerotherapy Needle received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212668.

Who is the listed applicant for Sclerotherapy Needle?

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

What is the FDA product code for Sclerotherapy Needle?

The FDA product code for Sclerotherapy Needle is FBK.

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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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