FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
K Number: K950242
·
Decision May 15, 1995
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
6
Review Days
115
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Basic Information
- Device Name
- ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
- K Number
- K950242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Argus Medical Co., Inc.
- Date Received
- January 20, 1995
- Decision Date
- May 15, 1995
- 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 Argus Medical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950255 | ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM | Aug 24, 1995 | Substantially Equivalent |
| K951624 | ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM | Jul 26, 1995 | Substantially Equivalent |
| K950297 | ARGUS ENDOSCOPIC PLASTIC SURGERY INSTRUMENT SYSTEM | Mar 3, 1995 | Substantially Equivalent |
| K946011 | ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM | Feb 17, 1995 | Substantially Equivalent |
| K950378 | ARGUS LAPAROSCOPY INSTRUMENT SYSTEM | Feb 9, 1995 | Substantially Equivalent |