Rusch Easycric Emergency Cricothyrotomy Set
FDA 510(k) K130405 · Teleflex Medical
510(k) numberK130405
Submission
- Device name
- Rusch Easycric Emergency Cricothyrotomy Set
- Applicant
- Teleflex Medical
Durham, NC, US - Received
- February 19, 2013
- Decision date
- November 6, 2013
- 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
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200190 | ScalpelCricBWC · Traditional | VBM Medizintechnik GmbH | 10/30/2020SE |
| K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy…BWC · Traditional | Cook Incorporated | 02/17/2017SE |
| K153761 | Emergency Transtracheal Airway CatheterBWC · Traditional | Cook Incorporated | 09/22/2016SE |
| 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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Questions and answers
When was Rusch Easycric Emergency Cricothyrotomy Set cleared by the FDA?
Rusch Easycric Emergency Cricothyrotomy Set (K130405) received a 510(k) decision of Substantially Equivalent on November 6, 2013, 260 days after the submission was received.
What is the product code of K130405?
The FDA product code is BWC – Needle, Emergency Airway, a Class II (moderate risk) device regulated under 21 CFR 868.5090.