FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TAVA WIRE-DRIVER
K Number: K935367
·
Decision Apr 21, 1994
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
7
Review Days
168
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Basic Information
- Device Name
- TAVA WIRE-DRIVER
- K Number
- K935367
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tava Surgical Instruments
- Date Received
- November 4, 1993
- Decision Date
- April 21, 1994
- Product Code
- HSZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Tava Surgical Instruments
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K863788 | SAWBLADE | Oct 14, 1986 | Substantially Equivalent |
| K854543 | PULSE LAVAGE | Jan 27, 1986 | Substantially Equivalent |