FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO-SUGICAL POWER INSTRUMENT SYSTEM
K Number: K802503
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
17
Applicant Total
5
Review Days
14
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Basic Information
- Device Name
- MICRO-SUGICAL POWER INSTRUMENT SYSTEM
- K Number
- K802503
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4140
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Spire Medical, Inc.
- Date Received
- October 17, 1980
- Decision Date
- October 31, 1980
- Product Code
- EQJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Spire Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821487 | MICRO-SURGICAL POWER INSTRUMENT SYS. | Jul 2, 1982 | Substantially Equivalent |
| K821485 | DERMABRADERS | Jun 10, 1982 | Substantially Equivalent |
| K821486 | MICRO DRILLS | Jun 9, 1982 | Substantially Equivalent |
| K802463 | MICRO-SURGICAL POWER INSTRUMENT SYSTEM | Oct 31, 1980 | Substantially Equivalent |