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FDA 510(k)

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

K-Number: K212857 · 2023-05-09

Decision Date2023-05-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Zhiyu Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K212857. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Jiangsu Zhiyu Medical Instrument Co, Ltd.. The 510(k) number is K212857.

When did Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use received FDA 510(k) clearance on 2023-05-09, under 510(k) number K212857.

Who is the listed applicant for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

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

What is the FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use?

The FDA product code for Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use is FMF.

Related Devices (Code: FMF)

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.

Official Source

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