FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HUDSON CRANINAL BURRS
K Number: K875224
·
Decision Jan 28, 1988
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
29
Review Days
37
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Basic Information
- Device Name
- HUDSON CRANINAL BURRS
- K Number
- K875224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Tri-Med, Inc.
- Date Received
- December 22, 1987
- Decision Date
- January 28, 1988
- 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)
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UniBur
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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 Tri-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040112 | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE | Mar 12, 2004 | Substantially Equivalent |
| K030877 | TRIMED RADIAL BULLET | Feb 5, 2004 | Substantially Equivalent |
| K010545 | TBW | Jun 6, 2001 | Substantially Equivalent |
| K961863 | PARACENTESIS TRAYS | May 28, 1996 | Substantially Equivalent |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | Apr 2, 1985 | Substantially Equivalent |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | Apr 2, 1985 | Substantially Equivalent |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | Apr 2, 1985 | Substantially Equivalent |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | Dec 4, 1984 | Substantially Equivalent |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | Nov 13, 1984 | Substantially Equivalent |
| K842399 | 48 HOUR SET CHANGES | Oct 9, 1984 | Substantially Equivalent |