FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
K Number: K875019
·
Decision Jan 22, 1988
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
17
Applicant Total
4
Review Days
49
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
- GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
- K Number
- K875019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4305
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Neurodynamics, Inc.
- Date Received
- December 4, 1987
- Decision Date
- January 22, 1988
- Product Code
- HBF
- 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 |
|---|---|---|---|
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBF), ordered by most recent decision date.
evoDrill Cranial Perforator
FDA 510(k)
FDA Class 2
·Neurology
NeuroLine Disposable Cranial Perforator with Hudson end
FDA 510(k)
FDA Class 2
·Neurology
Codman Disposable Perforators
FDA 510(k)
FDA Class 2
·Neurology
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
FDA 510(k)
FDA Class 2
·Neurology
MERIDIAN CRANIAL PERFORATOR
FDA 510(k)
FDA Class 2
·Neurology
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
FDA 510(k)
FDA Class 2
·Neurology