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FDA 510(k)

INJECTRA INJECTION NEEDLE

K-Number: K061222 · 2006-07-03

ApplicantMedi-Globe Corp.
Decision Date2006-07-03
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INJECTRA INJECTION NEEDLE 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 2006-07-03 under 510(k) number K061222. 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 INJECTRA INJECTION NEEDLE?

INJECTRA INJECTION NEEDLE is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Medi-Globe Corp.. The 510(k) number is K061222.

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

INJECTRA INJECTION NEEDLE received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061222.

Who is the listed applicant for INJECTRA INJECTION NEEDLE?

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 INJECTRA INJECTION NEEDLE?

The FDA product code for INJECTRA INJECTION NEEDLE 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.

K051247SONOTIP 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 SYSTEMK953355GIP/MEID-GLOBE HOT BIOPSY FORCEPS

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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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