FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CNS INTERCHANGEABLE BIT CRANIAL DRILL
K Number: K961113
·
Decision Jun 5, 1996
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- CNS INTERCHANGEABLE BIT CRANIAL DRILL
- K Number
- K961113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Neuro Systems, LLC
- Date Received
- March 20, 1996
- Decision Date
- June 5, 1996
- Product Code
- HBG
- 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 |
|---|---|---|---|
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | FDA class 2 | Neurology |
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Other Clearances by Clinical Neuro Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K930229 | CLINICAL NEURO SYSTEMS CRANIAL DRILL | Mar 16, 1993 | Substantially Equivalent |
| K922936 | CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE | Aug 26, 1992 | Substantially Equivalent |
| K922941 | CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA | Aug 26, 1992 | Substantially Equivalent |
| K920156 | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY | Mar 16, 1992 | Substantially Equivalent |