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FDA 510(k)

SONOTIP II ULTRASOUND NEEDLE SYSTEM

K-Number: K051247 · 2005-06-16

ApplicantMedi-Globe Corp.
Decision Date2005-06-16
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SONOTIP II ULTRASOUND NEEDLE SYSTEM 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 2005-06-16 under 510(k) number K051247. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOTIP II ULTRASOUND NEEDLE SYSTEM?

SONOTIP II ULTRASOUND NEEDLE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-16. The listed applicant is Medi-Globe Corp.. The 510(k) number is K051247.

When did SONOTIP II ULTRASOUND NEEDLE SYSTEM receive FDA 510(k) clearance?

SONOTIP II ULTRASOUND NEEDLE SYSTEM received FDA 510(k) clearance on 2005-06-16, under 510(k) number K051247.

Who is the listed applicant for SONOTIP II ULTRASOUND NEEDLE SYSTEM?

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 SONOTIP II ULTRASOUND NEEDLE SYSTEM?

The FDA product code for SONOTIP II ULTRASOUND NEEDLE SYSTEM is FCG.

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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 NEEDLEK011261STONE 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: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, 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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