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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 the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-02-08 under 510(k) 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. The listed applicant is Endochoice, Inc.. The 510(k) number is K151475.

When did EndoChoice Select Injection Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoChoice Select Injection Needle?

The FDA 510(k) record lists Endochoice, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for EndoChoice Select Injection Needle is FBK.

Other records listing Endochoice, Inc. 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.

K160275Fuse Endoscopic System with FuseBox ProcessorK161482EndoChoice Water Bottle Cap Irrigation SystemK161167Seal Single-Use Biopsy ValveK160403SmartStart Air/Water and Suction ValvesK153588EndoChoice Water Bottle Cap System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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