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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 a medical device manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under approval 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. It is manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K220292.

When was Disposable Endoscope Injection Needle approved by the FDA?

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

What company makes Disposable Endoscope Injection Needle?

Disposable Endoscope Injection Needle is manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd..

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

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

Related Clinical Trials

NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06606587 Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia COMPLETED NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT07542132 The Effects of Hyaluronic Acid on Skin Health NOT_YET_RECRUITING

Related PubMed Literature

PMID: 38645777 Risks and benefits associated with the primary functions of artificial intelligence powered autoinjectors. Frontiers in medical technology (2024) PMID: 38130421 Framework for creating a qualified medical device development tool of autoinjectors. Frontiers in medical technology (2023)

Other Devices by Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K222980Pentax Medical Valve Set K220785Clean Connecting Tube K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare K220210Disposable Endoscopy Adapter Set K230004Disposable Hemoclip K250732Disposable Endoscopy Valve Set

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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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