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FDA 510(k)

Blood Collection Needle (with/without Needle Holder)

K-Number: K223323 · 2023-03-24

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2023-03-24
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Blood Collection Needle (with/without Needle Holder) is a medical device manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-24 under approval number K223323. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blood Collection Needle (with/without Needle Holder)?

Blood Collection Needle (with/without Needle Holder) is a medical device that received FDA 510(k) clearance on 2023-03-24. It is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K223323.

When was Blood Collection Needle (with/without Needle Holder) approved by the FDA?

Blood Collection Needle (with/without Needle Holder) received FDA 510(k) clearance on 2023-03-24, under approval number K223323.

What company makes Blood Collection Needle (with/without Needle Holder)?

Blood Collection Needle (with/without Needle Holder) is manufactured by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..

What is the FDA product code for Blood Collection Needle (with/without Needle Holder)?

The FDA product code for Blood Collection Needle (with/without Needle Holder) is JKA.

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Other Devices by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K190183Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe K211555Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe K202188Safety Blood Collection Sets for Single Use K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K222141Safety Blood Collection Needle (Without Needle Holder) K220900Safety Blood Collection Needles with/without Needle Holder

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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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