FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO DRILLS
K Number: K821486
·
Decision Jun 9, 1982
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
2
Applicant Total
5
Review Days
22
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Basic Information
- Device Name
- MICRO DRILLS
- K Number
- K821486
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Spire Medical, Inc.
- Date Received
- May 18, 1982
- Decision Date
- June 9, 1982
- Product Code
- GFG
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GFG | Bit, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFG), ordered by most recent decision date.
MITEK MODULAR DRILL BIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KEY DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K802463 | MICRO-SURGICAL POWER INSTRUMENT SYSTEM | Oct 31, 1980 | Substantially Equivalent |
| K802503 | MICRO-SUGICAL POWER INSTRUMENT SYSTEM | Oct 31, 1980 | Substantially Equivalent |