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FDA 510(k)

Disposable Injection Needle AF series

K-Number: K230925 · 2023-09-27

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2023-09-27
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Injection Needle AF series is a medical device manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under approval number K230925. 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 Injection Needle AF series?

Disposable Injection Needle AF series is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K230925.

When was Disposable Injection Needle AF series approved by the FDA?

Disposable Injection Needle AF series received FDA 510(k) clearance on 2023-09-27, under approval number K230925.

What company makes Disposable Injection Needle AF series?

Disposable Injection Needle AF series is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd..

What is the FDA product code for Disposable Injection Needle AF series?

The FDA product code for Disposable Injection Needle AF series 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 NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING 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

Other Devices by Alton (Shanghai) Medical Instruments Co., Ltd.

K241285Disposable Endoscope Valves Set (AF series) K231633Disposable Hemoclip (AF series) K243039Ureteral Stents (AF-D series) K242635Endoscopic Distal Attachment (AF-D series) K241679Disposable Cytology Brush (AF series)

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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