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FDA 510(k)

VARICES INJECTION NEEDLE

K-Number: K012977 · 2001-11-02

ApplicantEndo-Therapeutics, Inc.
Decision Date2001-11-02
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VARICES INJECTION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Endo-Therapeutics, Inc.. It received FDA 510(k) clearance on 2001-11-02 under 510(k) number K012977. 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 VARICES INJECTION NEEDLE?

VARICES INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Endo-Therapeutics, Inc.. The 510(k) number is K012977.

When did VARICES INJECTION NEEDLE receive FDA 510(k) clearance?

VARICES INJECTION NEEDLE received FDA 510(k) clearance on 2001-11-02, under 510(k) number K012977.

Who is the listed applicant for VARICES INJECTION NEEDLE?

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

What is the FDA product code for VARICES INJECTION NEEDLE?

The FDA product code for VARICES INJECTION NEEDLE is FBK.

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Other records listing Endo-Therapeutics, Inc. as applicant

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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

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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