GHAJAR GUIDE TWIST DRILL
FDA 510(k) clearance K875018 · decided 1988-01-28
Clearance details
- K-number
- K875018
- Device name
- GHAJAR GUIDE TWIST DRILL
- Applicant
- Neurodynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-04
- Decision date
- 1988-01-28
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- HBG
- Device class
- 2
- Regulation number
- 882.4300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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| CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) | Clinical Neuro Systems, LLC | 1996-06-05 |
| MODIFICATION TO GHAJAR GUIDE TWIST DRILL (K932402) | Neurodynamics, Inc. | 1993-08-05 |
| PS MEDICAL VENTRICULOSTOMY KIT (K915546) | Pudenz-Schulte Medical Research Corp. | 1991-12-30 |
| PS MEDICAL CRANIAL HAND DRILL (K904283) | Pudenz-Schulte Medical Research Corp. | 1990-10-03 |
Recalls involving this device
No recalls on record reference this clearance.