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510(k) K200190

ScalpelCric by VBM Medizintechnik GmbH — Product Code BWC

K200190 is an FDA 510(k) premarket notification submitted by VBM Medizintechnik GmbH for the device "ScalpelCric". The FDA issued a decision of Substantially Equivalent on October 30, 2020. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090. VBM Medizintechnik GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
January 27, 2020
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 by VBM Medizintechnik GmbH

  • K112783 — MANUJET III (December 22, 2011)
  • K955461 — TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (March 19, 1997)

Other clearances for product code BWC

  • 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)
  • K952401 — ABELSON CRICOTHYROTOMY CANNULA (July 11, 1995)

FDA data resources