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FDA 510(k)

Injection Needle

K-Number: K260262 · 2026-05-29

ApplicantMirco-Tech (Nanjing) Co., Ltd.
Decision Date2026-05-29
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260262. 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 Injection Needle?

Injection Needle is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Mirco-Tech (Nanjing) Co., Ltd.. The 510(k) number is K260262.

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

Injection Needle received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260262.

Who is the listed applicant for Injection Needle?

The FDA 510(k) record lists Mirco-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Injection Needle?

The FDA product code for Injection Needle is FBK.

Other records listing Mirco-Tech (Nanjing) Co., Ltd. as applicant

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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.

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.K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp.

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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