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FDA 510(k)

GIP/MEDI-GLOBE PAPILLOTOME

K-Number: K943629 · 1995-05-26

ApplicantMedi-Globe Corp.
Decision Date1995-05-26
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIP/MEDI-GLOBE PAPILLOTOME 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 1995-05-26 under 510(k) number K943629. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIP/MEDI-GLOBE PAPILLOTOME?

GIP/MEDI-GLOBE PAPILLOTOME is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Medi-Globe Corp.. The 510(k) number is K943629.

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

GIP/MEDI-GLOBE PAPILLOTOME received FDA 510(k) clearance on 1995-05-26, under 510(k) number K943629.

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

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 PAPILLOTOME?

The FDA product code for GIP/MEDI-GLOBE PAPILLOTOME is KNS.

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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: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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