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FDA 510(k)

GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES

K-Number: K955558 · 1996-02-29

ApplicantMedi-Globe Corp.
Decision Date1996-02-29
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corp.. It received FDA 510(k) clearance on 1996-02-29 under 510(k) number K955558. 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 GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES?

GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES is a medical device that received FDA 510(k) clearance on 1996-02-29. The listed applicant is Medi-Globe Corp.. The 510(k) number is K955558.

When did GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES receive FDA 510(k) clearance?

GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES received FDA 510(k) clearance on 1996-02-29, under 510(k) number K955558.

Who is the listed applicant for GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES?

The FDA 510(k) record lists Medi-Globe Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES?

The FDA product code for GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES is FBK.

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Other records listing Medi-Globe Corp. 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.

K061222INJECTRA INJECTION NEEDLEK051247SONOTIP II ULTRASOUND NEEDLE SYSTEMK011261STONE EXTRACTOR BALLOON CATHETERK010714EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830K010549BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)K990220MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

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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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