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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 a medical device manufactured by Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-28 under approval 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. It is manufactured by Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210917.

When was Single Use Injection Needle approved by the FDA?

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

What company makes Single Use Injection Needle?

Single Use Injection Needle is manufactured by Anrei Medical (Hangzhou) Co., Ltd..

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

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

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Anrei Medical (Hangzhou) Co., Ltd.

K201771Single Use Rotatable and Repositionable Hemoclip K192048Single Use Endoscope Valves Set K202987Rescue Pulmonary Grasping Forceps K210660Stone Retrieval Balloon Catheter K212999Multi-Functional Electrosurgical Knife

Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K151475EndoChoice Select Injection NeedleEndochoice, Inc. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix Co., Ltd.

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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