FDA 510(k)

Sterile syringe for single use with/without needle

K-Number: K210227 · 2021-09-10

ApplicantZhejiang Kangkang Medical-Devices Co., Ltd.

Decision Date2021-09-10

Product CodeFMF

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sterile syringe for single use with/without needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K210227. 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/without needle?

Sterile syringe for single use with/without needle is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210227.

When did Sterile syringe for single use with/without needle receive FDA 510(k) clearance?

Sterile syringe for single use with/without needle received FDA 510(k) clearance on 2021-09-10, under 510(k) number K210227.

Who is the listed applicant for Sterile syringe for single use with/without needle?

The FDA 510(k) record lists Zhejiang Kangkang Medical-Devices 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/without needle?

The FDA product code for Sterile syringe for single use with/without needle is FMF.

Other records listing Zhejiang Kangkang Medical-Devices 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.

K213535Sterile Safety Hypodermic Needles for Single Use K210229Sterile Auto-Disable Syringes with/without Needle for Single Use K210232Sterile Hypodermic Needles for Single Use

Related Devices (Code: FMF)

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.