FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTHRO AUTOMAT 5002
K Number: K871180
·
Decision Sep 29, 1987
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
12
Review Days
188
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Basic Information
- Device Name
- ARTHRO AUTOMAT 5002
- K Number
- K871180
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- F.M. Wiest USA, Inc.
- Date Received
- March 25, 1987
- Decision Date
- September 29, 1987
- 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 F.M. Wiest USA, Inc.
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|---|---|---|---|
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| K920574 | CAMSYS 6300 | Feb 17, 1993 | Substantially Equivalent |
| K920575 | MERKUR 4000 | Jul 23, 1992 | Substantially Equivalent |
| K915751 | URETEROMAT 4400 | Apr 24, 1992 | Substantially Equivalent |
| K911844 | HYSTEROFLATOR 1500 | Nov 21, 1991 | Substantially Equivalent |
| K912071 | SPACE(TM) 7500 | Jul 9, 1991 | Substantially Equivalent |
| K910883 | LAPAROFLATOR ELECTRONIC 3509 | Mar 29, 1991 | Substantially Equivalent |
| K875137 | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC | Mar 2, 1988 | Substantially Equivalent |
| K871181 | ARTHROCOMBI 5003 | Sep 29, 1987 | Substantially Equivalent |
| K865066 | ARTHROFLATOR | Apr 20, 1987 | Substantially Equivalent |