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FDA 510(k)

Injection Needle

K-Number: K213914 · 2022-07-29

ApplicantJiangsu Vedkang Medical Science and Technology Co., Ltd.
Decision Date2022-07-29
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Injection Needle is a medical device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under approval number K213914. 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 2022-07-29. It is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K213914.

When was Injection Needle approved by the FDA?

Injection Needle received FDA 510(k) clearance on 2022-07-29, under approval number K213914.

What company makes Injection Needle?

Injection Needle is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd..

What is the FDA product code for Injection Needle?

The FDA product code for 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

Other Devices by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K220089Disposable Polyp Snare K230598Stone Extraction Baskets K222146Disposable Endoscopic Hemoclip K232825Disposable Sphincterotome K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)

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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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