Product code BWC— Anesthesiology
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
- Classification name
- Needle, Emergency Airway
- Device class
- Class 2
- Regulation
- 21 CFR 868.5090
- Advisory panel
- Anesthesiology
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code BWC
FDA has cleared devices under product code BWC between 1977 and 2020, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2017
- 2016
- 2013
- 2005
- 2002
- 2001
- 1997
- 1995
- 1985
- 1979
- 1977
Top applicants under product code BWC
Recent clearances under product code BWC
- K200190 — ScalpelCric
- K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- K153761 — Emergency Transtracheal Airway Catheter
- K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
- K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
- K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
- K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
- K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
- K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER
- K962312 — KEY CHAIN EMERGENCY AIRWAY
- K952401 — ABELSON CRICOTHYROTOMY CANNULA
- K853345 — 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
- K790650 — WEISS EMERGENCY AIRWAY SYSTEM
- K771587 — INSTANT AIR
Data sourced from openFDA. This site is unofficial and independent of the FDA.