FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANNULA MODEL AR-6551
K Number: K881792
·
Decision Jul 7, 1988
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
2
Review Days
72
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Basic Information
- Device Name
- CANNULA MODEL AR-6551
- K Number
- K881792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Arthrex Arthroscopy Instruments, Inc.
- Date Received
- April 26, 1988
- Decision Date
- July 7, 1988
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Arthrex Arthroscopy Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880295 | CANNULA MODEL AR-6001 | Jun 29, 1988 | Substantially Equivalent |