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FDA 510(k)

Endoscopic Injection Needle

K-Number: K213239 · 2022-06-02

ApplicantBeijing Zksk Technology Co., Ltd.
Decision Date2022-06-02
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K213239. 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 Endoscopic Injection Needle?

Endoscopic Injection Needle is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Beijing Zksk Technology Co., Ltd.. The 510(k) number is K213239.

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

Endoscopic Injection Needle received FDA 510(k) clearance on 2022-06-02, under 510(k) number K213239.

Who is the listed applicant for Endoscopic Injection Needle?

The FDA 510(k) record lists Beijing Zksk Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscopic Injection Needle?

The FDA product code for Endoscopic Injection Needle is FBK.

Related Clinical Trials

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.

NCT07754955Comparison of Efficacy and Safety of Speedboat Device and Needle Knife for Colorectal Endoscopic Submucosal Dissection: a Multicenter Randomized StudyRECRUITING

Other records listing Beijing Zksk Technology 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.

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

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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