FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL BUR
K Number: K872475
·
Decision Jul 2, 1987
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
15
Applicant Total
7
Review Days
9
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGICAL BUR
- K Number
- K872475
- 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
- June 23, 1987
- Decision Date
- July 2, 1987
- Product Code
- GFF
- 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 |
|---|---|---|---|
| GFF | Bur, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFF), ordered by most recent decision date.
ANSPACH SHIELDED ATTACHMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL BUR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL BUR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BURRS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DANEK IRRIGATING BURR (DIB) SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K863788 | SAWBLADE | Oct 14, 1986 | Substantially Equivalent |
| K854543 | PULSE LAVAGE | Jan 27, 1986 | Substantially Equivalent |