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FDA 510(k)

EndoChoice Select Injection Needle

K-Number: K151475 · 2016-02-08

ApplicantEndochoice, Inc.
Decision Date2016-02-08
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoChoice Select Injection Needle is a medical device manufactured by Endochoice, Inc.. It received FDA 510(k) clearance on 2016-02-08 under approval number K151475. 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 EndoChoice Select Injection Needle?

EndoChoice Select Injection Needle is a medical device that received FDA 510(k) clearance on 2016-02-08. It is manufactured by Endochoice, Inc.. The 510(k) number is K151475.

When was EndoChoice Select Injection Needle approved by the FDA?

EndoChoice Select Injection Needle received FDA 510(k) clearance on 2016-02-08, under approval number K151475.

What company makes EndoChoice Select Injection Needle?

EndoChoice Select Injection Needle is manufactured by Endochoice, Inc..

What is the FDA product code for EndoChoice Select Injection Needle?

The FDA product code for EndoChoice Select 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 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 Endochoice, Inc.

K160275Fuse Endoscopic System with FuseBox Processor K161482EndoChoice Water Bottle Cap Irrigation System K161167Seal Single-Use Biopsy Valve K160403SmartStart Air/Water and Suction Valves K153588EndoChoice Water Bottle Cap System

Related Devices (Code: FBK)

K153625Single Use Injector NM600/610Olympus Medical Systems Corp. K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. K171602Williams Cystoscopic Injection NeedleCook Incorporated K171454Interject Injection Therapy Needle CatheterBoston Scientific Corporation K181690Clear-Jet Injection CatheterFinemedix Co., Ltd. K180214Repris Bladder Injection SystemUro-1, Inc.

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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