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FDA 510(k)

GIP/MEDI-GLOBE ERCP CATHETERS

K-Number: K953827 · 1995-09-01

Decision Date1995-09-01
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIP/MEDI-GLOBE ERCP CATHETERS 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 1995-09-01 under 510(k) number K953827. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIP/MEDI-GLOBE ERCP CATHETERS?

GIP/MEDI-GLOBE ERCP CATHETERS is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Medi-Globe Corp.. The 510(k) number is K953827.

When did GIP/MEDI-GLOBE ERCP CATHETERS receive FDA 510(k) clearance?

GIP/MEDI-GLOBE ERCP CATHETERS received FDA 510(k) clearance on 1995-09-01, under 510(k) number K953827.

Who is the listed applicant for GIP/MEDI-GLOBE ERCP CATHETERS?

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 ERCP CATHETERS?

The FDA product code for GIP/MEDI-GLOBE ERCP CATHETERS is FGE.

Related Clinical Trials

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.

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.

View all 18 devices →

Related Devices (Code: FGE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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