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FDA 510(k)

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM

K-Number: K091257 · 2009-05-08

ApplicantMedi-Globe Corporation
Decision Date2009-05-08
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe Corporation. It received FDA 510(k) clearance on 2009-05-08 under 510(k) number K091257. 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 MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM?

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-08. The listed applicant is Medi-Globe Corporation. The 510(k) number is K091257.

When did MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM receive FDA 510(k) clearance?

MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM received FDA 510(k) clearance on 2009-05-08, under 510(k) number K091257.

Who is the listed applicant for MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM?

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

What is the FDA product code for MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM?

The FDA product code for MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM is FCG.

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Other records listing Medi-Globe Corporation 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.

K153264EasyPass GuidewireK083802SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025K070129SONOTIP II ULTRASOUND NEEDLE SYSTEMK061684MEDI-GLOBE ROTA-CUT SPHINCTEROTOME

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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