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Medi-Globe Papillotome

FDA 510(k)

Class II (US FDA 510(k))

510(k) K943629

by Medi-Globe Corp.

Identifiers

510(k) Number
K943629 FDA 510(k)
FDA Product Code
KNS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4300 FDA 510(k)
Regulation Number
876.4300 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medi-Globe Papillotome is an electrosurgical, endoscopic device designed for cutting and excising tissue, primarily used in endoscopic procedures. It falls under the classification of a unit, electrosurgical, endoscopic instrument, enabling precise tissue manipulation during gastrointestinal and urological interventions. The device operates via electrosurgical energy to perform controlled incisions or resections, aiding in procedures such as sphincterotomy or stricturotomy.

This device is supplied as a single-use or reusable instrument, depending on manufacturer guidelines, and is intended for use in sterile settings such as operating rooms or endoscopy suites. It is classified under FDA regulation 876.4300 and holds a 510(k) clearance (K943629) for substantial equivalence in the Gastroenterology and Urology specialties. Compliance with electrosurgical safety standards is required, and its use must adhere to established medical protocols for endoscopic procedures.

Frequently asked questions

What is the Medi-Globe Papillotome used for?

The Medi-Globe Papillotome is an electrosurgical device designed for cutting and excising tissue during endoscopic procedures. It is primarily used in gastroenterology and urology for controlled incisions or resections, such as sphincterotomy or stricturotomy, where precise tissue manipulation is required. The device delivers electrosurgical energy to achieve these outcomes safely and effectively.

Is the Medi-Globe Papillotome single-use or reusable?

The Medi-Globe Papillotome can be supplied as either single-use or reusable, depending on the manufacturer’s guidelines. If reused, it must undergo proper cleaning, sterilization, and maintenance to ensure safety and functionality. Always follow the manufacturer’s instructions to determine the appropriate use case for your clinical setting.

What regulatory approval does the Medi-Globe Papillotome hold?

The Medi-Globe Papillotome holds FDA 510(k) clearance (K943629) under the classification of a unit, electrosurgical, endoscopic instrument. This clearance establishes substantial equivalence to a predicate device and confirms compliance with FDA regulations (876.4300) for use in endoscopic procedures within gastroenterology and urology. The device must adhere to electrosurgical safety standards and established medical protocols.

How should the Medi-Globe Papillotome be stored?

The Medi-Globe Papillotome should be stored in a clean, dry environment, protected from moisture, dust, and direct sunlight. If reusable, it must be stored according to the manufacturer’s instructions, typically in a sterile or clean packaging until ready for use. For single-use devices, ensure proper handling and storage to maintain sterility until the procedure.

What medical specialties is the Medi-Globe Papillotome approved for?

The Medi-Globe Papillotome is approved for use in gastroenterology and urology specialties. Its design and FDA clearance (K943629) specifically support procedures like sphincterotomy or stricturotomy, where controlled tissue excision is required. Always verify intended use with the manufacturer’s guidelines and local regulatory requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K943629 FDA 510 (k) - GIP/MEDI-GLOBE PAPILLOTOME, GIP/MEDI-GLOBE PAPILLOTOME (K943629) — FDA 510(k) | Innolitics, GIP/MEDI-GLOBE PAPILLOTOME 510(k) K943629 - FDA.report, Gip/Medi-globe Papillotome - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medi-Globe Corp.

Sources (1)

  • FDA 510(k) K943629 24 fields · synced Oct 1, 2026