FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAWBLADE
K Number: K863788
·
Decision Oct 14, 1986
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
26
Applicant Total
7
Review Days
18
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Basic Information
- Device Name
- SAWBLADE
- K Number
- K863788
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Tava Surgical Instruments
- Date Received
- September 26, 1986
- Decision Date
- October 14, 1986
- Product Code
- GFA
- 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 |
|---|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFA), ordered by most recent decision date.
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RE-SHARPENABLE SAW BLADES
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Other Clearances by Tava Surgical Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K935367 | TAVA WIRE-DRIVER | Apr 21, 1994 | Substantially Equivalent |
| K940109 | TAVA K-WIRE | Feb 22, 1994 | Substantially Equivalent |
| K885273 | MICRO SURGICAL INSTRUMENT SYSTEM | Jan 30, 1989 | Substantially Equivalent |
| K884492 | MICRO SURGICAL INSTRUMENT SYSTEM | Nov 16, 1988 | Substantially Equivalent |
| K872475 | SURGICAL BUR | Jul 2, 1987 | Substantially Equivalent |
| K854543 | PULSE LAVAGE | Jan 27, 1986 | Substantially Equivalent |