FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINICAL NEURO SYSTEMS CRANIAL DRILL
K Number: K930229
·
Decision Mar 16, 1993
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
5
Review Days
56
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
- CLINICAL NEURO SYSTEMS CRANIAL DRILL
- K Number
- K930229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Clinical Neuro Systems, LLC
- Date Received
- January 19, 1993
- Decision Date
- March 16, 1993
- Product Code
- HBE
- 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 |
|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBE), ordered by most recent decision date.
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
FDA 510(k)
FDA Class 2
·Neurology
Hubly Drill (H100)
FDA 510(k)
FDA Class 2
·Neurology
GREEN
FDA 510(k)
FDA Class 2
·Neurology
UniBur
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Clinical Neuro Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Jun 5, 1996 | 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 |