ARTHROSCOPE
FDA 510(k) clearance K971083 · decided 1997-06-23
Clearance details
- K-number
- K971083
- Device name
- ARTHROSCOPE
- Applicant
- Electro-Biology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-25
- Decision date
- 1997-06-23
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EBI VueCath Endoscopic Spinal System recall (Z-1006-03) | EBI, L.P. | 2003-07-15 |