FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ScalpelCric
K Number: K200190
·
Decision Oct 30, 2020
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
3
Review Days
277
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ScalpelCric
- K Number
- K200190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5090
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VBM Medizintechnik GmbH
- Date Received
- January 27, 2020
- Decision Date
- October 30, 2020
- Product Code
- BWC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BWC | Needle, Emergency Airway | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWC), ordered by most recent decision date.
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
FDA 510(k)
FDA Class 2
·Anesthesiology
Emergency Transtracheal Airway Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
FDA 510(k)
FDA Class 2
·Anesthesiology
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
FDA 510(k)
FDA Class 2
·Anesthesiology
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
FDA 510(k)
FDA Class 2
·Anesthesiology