FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-AIRE MODEL NUMBER: MK-426
K Number: K905097
·
Decision Dec 21, 1990
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
15
Review Days
38
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Basic Information
- Device Name
- MICRO-AIRE MODEL NUMBER: MK-426
- K Number
- K905097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro Surgical Instruments Corp.
- Date Received
- November 13, 1990
- Decision Date
- December 21, 1990
- 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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GREEN
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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 Micro Surgical Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931395 | SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K932492 | IMPLANTOLOGY MODULE, MODEL 2175 | Oct 5, 1993 | Substantially Equivalent |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Aug 2, 1993 | Substantially Equivalent |
| K914998 | MICROAIRE(R) FACIAL BONE PLATING SYSTEM | Jun 2, 1992 | Substantially Equivalent |
| K915139 | MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE | Feb 5, 1992 | Substantially Equivalent |
| K914346 | DRILL MODULES MODELS 2116/2117 | Nov 27, 1991 | Substantially Equivalent |
| K913369 | MICRO-AIRE MODEL 2060 | Nov 1, 1991 | Substantially Equivalent |
| K913266 | MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS | Oct 21, 1991 | Substantially Equivalent |
| K910175 | FIXATION DEVICES AND BONE PLATE | Jun 21, 1991 | Substantially Equivalent for Some Indications |
| K905383 | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | Jun 18, 1991 | Substantially Equivalent |