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510(k) K952401

ABELSON CRICOTHYROTOMY CANNULA by Gilbert Surgical Instruments, Inc. — Product Code BWC

K952401 is an FDA 510(k) premarket notification submitted by Gilbert Surgical Instruments, Inc. for the device "ABELSON CRICOTHYROTOMY CANNULA". The FDA issued a decision of Substantially Equivalent on July 11, 1995. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
May 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Emergency Airway
Device Class
Class II
Regulation Number
868.5090
Review Panel
AN
Submission Type

Other clearances for product code BWC

  • K200190 — ScalpelCric (October 30, 2020)
  • K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyr (February 17, 2017)
  • K153761 — Emergency Transtracheal Airway Catheter (September 22, 2016)
  • K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (November 6, 2013)
  • K050166 — PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (May 26, 2005)
  • K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (December 20, 2001)
  • K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (October 9, 2001)
  • K962312 — KEY CHAIN EMERGENCY AIRWAY (June 17, 1997)

FDA data resources