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FDA 510(k)

Disposable Endoscope Injection Needle

K-Number: K220292 · 2022-08-19

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2022-08-19
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscope Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220292. 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 Disposable Endoscope Injection Needle?

Disposable Endoscope Injection Needle is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K220292.

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

Disposable Endoscope Injection Needle received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220292.

Who is the listed applicant for Disposable Endoscope Injection Needle?

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

What is the FDA product code for Disposable Endoscope Injection Needle?

The FDA product code for Disposable Endoscope Injection Needle is FBK.

Other records listing Yangzhou Fartley Medical Instrument Technology 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.

K260423Disposable Endoscopic Distal AttachmentsK250732Disposable Endoscopy Valve SetK230004Disposable HemoclipK222980Pentax Medical Valve SetK220785Clean Connecting TubeK220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

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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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