BWC — Needle, Emergency Airway Class II
FDA product code BWC covers "Needle, Emergency Airway", a Class II medical device regulated under 21 CFR 868.5090. Submissions are reviewed by the Anesthesiology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BWC
- Device Class
- Class II
- Regulation Number
- 868.5090
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200190 | vbm medizintechnik | ScalpelCric | October 30, 2020 |
| K160200 | cook incorporated | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyr | February 17, 2017 |
| K153761 | cook incorporated | Emergency Transtracheal Airway Catheter | September 22, 2016 |
| K130405 | teleflex medical | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | November 6, 2013 |
| K050166 | smiths medical | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | May 26, 2005 |
| K013241 | cook | ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET | February 21, 2002 |
| K013252 | cook | PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET | February 21, 2002 |
| K013916 | cook | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET | December 20, 2001 |
| K010016 | cook | MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER | October 9, 2001 |
| K962312 | ffrench pocket emergency airway | KEY CHAIN EMERGENCY AIRWAY | June 17, 1997 |
| K952401 | gilbert surgical instruments | ABELSON CRICOTHYROTOMY CANNULA | July 11, 1995 |
| K853345 | 31st. centruy medical | 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE | October 1, 1985 |
| K790650 | intl. medical devices | WEISS EMERGENCY AIRWAY SYSTEM | June 27, 1979 |
| K771587 | hyde, vernon e., d.d.s | INSTANT AIR | September 2, 1977 |