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Guide Wire for EDI Catheter, 8FR, 125CM, 5 Each

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K101199

by Maquet Critical Care AB

Identifiers

510(k) Number
K101199 FDA 510(k)
FDA Product Code
KNT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a guide wire designed for use with an EDI (Endoscopic Drainage and Irrigation) catheter. Guide wires are flexible, steerable instruments used to navigate and position catheters within the biliary or urinary tract during endoscopic procedures, facilitating drainage, irrigation, or diagnostic access.

The guide wire is supplied in a sterile, single-use package, available in an 8 French (FR) diameter and 125 cm length, with a pack size of five. It is intended for use in controlled clinical settings such as endoscopy suites and is compliant with FDA 510(k) clearance under the Gastroenterology and Urology advisory committees, as well as MDR requirements. No MRI safety information is specified.

Frequently asked questions

What is the primary use of this guide wire in medical procedures?

This guide wire is specifically designed to assist in navigating and positioning an EDI (Endoscopic Drainage and Irrigation) catheter within the biliary or urinary tract during endoscopic procedures. Its flexibility and steerability help facilitate drainage, irrigation, or diagnostic access, ensuring precise placement of the catheter.

Is this guide wire intended for reuse, or is it meant to be used only once?

This guide wire is supplied as a single-use device in a sterile package. It is intended for one-time use in controlled clinical settings like endoscopy suites, ensuring patient safety and sterility standards are maintained.

What are the dimensions and packaging details of this guide wire?

The guide wire has an 8 French (FR) diameter and a length of 125 cm. It is supplied in packs of five wires per package, which are individually sterile to meet clinical requirements.

How should this guide wire be stored, and what are the key considerations?

Since the guide wire is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure the seal remains intact to preserve sterility until use.

What regulatory pathways does this guide wire follow, and which committees were involved?

This guide wire is compliant with FDA 510(k) clearance, determined to be substantially equivalent under the Gastroenterology and Urology advisory committees. It also meets MDR (Medical Device Regulation) requirements, ensuring adherence to both U.S. and EU regulatory standards.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Maquet Critical Care AB

Sources (2)

  • FDA 510(k) K101199 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026