FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ALPHA DRIVE SYSTEM
K Number: K013396
·
Decision Aug 7, 2002
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
4
Review Days
296
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
- ALPHA DRIVE SYSTEM
- K Number
- K013396
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alpha Omega , Ltd.
- Date Received
- October 15, 2001
- Decision Date
- August 7, 2002
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAW), ordered by most recent decision date.
Zeta Navigation System
FDA 510(k)
FDA Class 2
·Neurology
Stealth AXiS Cranial clinical application
FDA 510(k)
FDA Class 2
·Neurology
NeuroAlign software
FDA 510(k)
FDA Class 2
·Neurology
SOLOPASS 2.0 System
FDA 510(k)
FDA Class 2
·Neurology
Ball Joint Guide Array (66295)
FDA 510(k)
FDA Class 2
·Neurology
EZ-FIDUCIALS
FDA 510(k)
FDA Class 2
·Neurology