Atlas FDA

ScalpelCric

FDA 510(k) clearance K200190 · decided 2020-10-30

Clearance details

K-number
K200190
Device name
ScalpelCric
Applicant
VBM Medizintechnik GmbH
Decision
Substantially Equivalent
Date received
2020-01-27
Decision date
2020-10-30
Days to decision
277 days
Clearance type
Traditional
Product code
BWC
Device class
2
Regulation number
868.5090
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Sulz Am Neckar, DE
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (K130405)Teleflex Medical2013-11-06
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166)Smiths Medical2005-05-26
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (K013241)Cook, Inc.2002-02-21
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (K013252)Cook, Inc.2002-02-21
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916)Cook, Inc.2001-12-20
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016)Cook, Inc.2001-10-09
KEY CHAIN EMERGENCY AIRWAY (K962312)Ffrench Pocket Emergency Airway, Inc.1997-06-17
ABELSON CRICOTHYROTOMY CANNULA (K952401)Gilbert Surgical Instruments, Inc.1995-07-11
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345)31st. Centruy Medical Corp.1985-10-01
WEISS EMERGENCY AIRWAY SYSTEM (K790650)Intl. Medical Devices , Ltd.1979-06-27

Recalls involving this device

No recalls on record reference this clearance.