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FDA 510(k)

Single Use Injection Needle

K-Number: K210917 · 2021-05-28

ApplicantAnrei Medical (Hangzhou) Co., Ltd.
Decision Date2021-05-28
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K210917. 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 Single Use Injection Needle?

Single Use Injection Needle is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210917.

When did Single Use Injection Needle receive FDA 510(k) clearance?

Single Use Injection Needle received FDA 510(k) clearance on 2021-05-28, under 510(k) number K210917.

Who is the listed applicant for Single Use Injection Needle?

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

What is the FDA product code for Single Use Injection Needle?

The FDA product code for Single Use Injection Needle is FBK.

Other records listing Anrei Medical (Hangzhou) 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.

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Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

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.

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