FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTRIC WIRE DRIVER, MODEL 2640E
K Number: K930205
·
Decision Aug 2, 1993
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
5
Applicant Total
15
Review Days
199
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Basic Information
- Device Name
- ELECTRIC WIRE DRIVER, MODEL 2640E
- K Number
- K930205
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Surgical Instruments Corp.
- Date Received
- January 15, 1993
- Decision Date
- August 2, 1993
- Product Code
- HXJ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HXJ | Staple Driver | FDA class 1 | Orthopedic |
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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 |
| 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 |
| K905207 | MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS | Jan 22, 1991 | Substantially Equivalent for Some Indications |