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FDA 510(k)

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME

K-Number: K061684 · 2006-06-27

ApplicantMedi-Globe Corporation
Decision Date2006-06-27
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME 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 2006-06-27 under 510(k) number K061684. 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 MEDI-GLOBE ROTA-CUT SPHINCTEROTOME?

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME is a medical device that received FDA 510(k) clearance on 2006-06-27. The listed applicant is Medi-Globe Corporation. The 510(k) number is K061684.

When did MEDI-GLOBE ROTA-CUT SPHINCTEROTOME receive FDA 510(k) clearance?

MEDI-GLOBE ROTA-CUT SPHINCTEROTOME received FDA 510(k) clearance on 2006-06-27, under 510(k) number K061684.

Who is the listed applicant for MEDI-GLOBE ROTA-CUT SPHINCTEROTOME?

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 ROTA-CUT SPHINCTEROTOME?

The FDA product code for MEDI-GLOBE ROTA-CUT SPHINCTEROTOME is KNS.

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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 GuidewireK091257MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEMK083802SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025K070129SONOTIP II ULTRASOUND NEEDLE SYSTEM

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

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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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