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FDA 510(k)

NEEDLE

K-Number: K924102 · 1992-11-25

ApplicantUnited States Endoscopy Group, Inc.
Decision Date1992-11-25
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K924102. 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 NEEDLE?

NEEDLE is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K924102.

When did NEEDLE receive FDA 510(k) clearance?

NEEDLE received FDA 510(k) clearance on 1992-11-25, under 510(k) number K924102.

Who is the listed applicant for NEEDLE?

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

What is the FDA product code for NEEDLE?

The FDA product code for NEEDLE is FBK.

Related Clinical Trials

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Related PubMed Literature

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.

PMID: 30016051General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order.Federal register ()

Other records listing United States Endoscopy Group, 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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