Melker Cuffed Emergency Cricothyrotomy Catheter
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K010016 FDA 510(k)
- FDA Product Code
- BWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5090 FDA 510(k)
- Regulation Number
- 868.5090 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Melker Cuffed Emergency Cricothyrotomy Catheter is a device designed to establish emergency airway access when endotracheal intubation cannot be performed. It utilizes the percutaneous entry (Seldinger) technique via the cricothyroid membrane to create an airway. The catheter is cuffed to help secure and maintain the airway once established.
This device is supplied as a single-use set and is intended for emergency situations where conventional airway management is not possible. It is regulated as a Class II device with FDA 510(k) clearance under product code BWC. The device is manufactured by Cook, Inc. and is designed for use in anesthesiology and emergency medical settings.
Frequently asked questions
What is the Melker Cuffed Emergency Cricothyrotomy Catheter used for?
The Melker Cuffed Emergency Cricothyrotomy Catheter is designed to establish emergency airway access when endotracheal intubation cannot be performed. It utilizes the percutaneous entry (Seldinger) technique via the cricothyroid membrane to create an airway in emergency situations.
How is the Melker Cuffed Emergency Cricothyrotomy Catheter supplied?
The device is supplied as a single-use set, meaning it comes pre-packaged with all necessary components for one-time use. This ensures sterility and prevents cross-contamination between patients.
Is the Melker Cuffed Emergency Cricothyrotomy Catheter reusable?
No, the Melker Cuffed Emergency Cricothyrotomy Catheter is designed for single-use only. It should not be reused on multiple patients as this could compromise sterility and patient safety.
What regulatory status does the Melker Cuffed Emergency Cricothyrotomy Catheter have?
The device is regulated as a Class II device with FDA 510(k) clearance under product code BWC. It received clearance in 2001 and is intended for use in anesthesiology and emergency medical settings.
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: Melker Cuffed Emergency Cricothyrotomy Catheter Set - Cook Medical, Melker Emergency Cricothyrotomy Catheter Set - Cuffed - Cook Medical, Melker Cuffed Emergency Cricothyrotomy Catheter Set - Cook Medical, Emergency Airway Products - Cook Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010016 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K010016 24 fields · synced Sep 25, 2026