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FDA 510(k)

ENTERYX INJECTOR

K-Number: K013712 · 2002-05-31

ApplicantEnteric Medical Technologies
Decision Date2002-05-31
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTERYX INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Enteric Medical Technologies. It received FDA 510(k) clearance on 2002-05-31 under 510(k) number K013712. 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 ENTERYX INJECTOR?

ENTERYX INJECTOR is a medical device that received FDA 510(k) clearance on 2002-05-31. The listed applicant is Enteric Medical Technologies. The 510(k) number is K013712.

When did ENTERYX INJECTOR receive FDA 510(k) clearance?

ENTERYX INJECTOR received FDA 510(k) clearance on 2002-05-31, under 510(k) number K013712.

Who is the listed applicant for ENTERYX INJECTOR?

The FDA 510(k) record lists Enteric Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERYX INJECTOR?

The FDA product code for ENTERYX INJECTOR is FBK.

Related Clinical Trials

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.

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Other records listing Enteric Medical Technologies 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.

K000646DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

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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