Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
FDA 510(k) K160200 · Cook Incorporated
510(k) numberK160200
Submission
- Device name
- Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- January 28, 2016
- Decision date
- February 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWC – Needle, Emergency Airway
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5090
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200190 | ScalpelCricBWC · Traditional | VBM Medizintechnik GmbH | 10/30/2020SE |
| K153761 | Emergency Transtracheal Airway CatheterBWC · Traditional | Cook Incorporated | 09/22/2016SE |
| K130405 | Rusch Easycric Emergency Cricothyrotomy SetBWC · Traditional | Teleflex Medical | 11/06/2013SE |
| K050166 | Portex Emergency Cricothyroidotomy KitBWC · Traditional | Smiths Medical | 05/26/2005SE |
| K013252 | Patil Emergency Cricothyrotomy Catheter SetBWC · Traditional | Cook, Inc. | 02/21/2002SE |
| K013241 | Arndt Emergency Cricothyrotomy Catheter SetBWC · Traditional | Cook, Inc. | 02/21/2002SE |
| K013916 | Melker Emergency Cricothyrotomy Catheter SetBWC · Traditional | Cook, Inc. | 12/20/2001SE |
| K010016 | Melker Cuffed Emergency Cricothyrotomy CatheterBWC · Traditional | Cook, Inc. | 10/09/2001SE |
| K962312 | Key Chain Emergency AirwayBWC · Traditional | Ffrench Pocket Emergency Airway, Inc. | 06/17/1997SE |
| K952401 | Abelson Cricothyrotomy CannulaBWC · Traditional | Gilbert Surgical Instruments, Inc. | 07/11/1995SE |
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| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
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Questions and answers
When was Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set cleared by the FDA?
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200) received a 510(k) decision of Substantially Equivalent on February 17, 2017, 386 days after the submission was received.
What is the product code of K160200?
The FDA product code is BWC – Needle, Emergency Airway, a Class II (moderate risk) device regulated under 21 CFR 868.5090.