MICROSPEED UNI MOTOR SYSTEM
FDA 510(k) clearance K053526 · decided 2006-01-18
Clearance details
- K-number
- K053526
- Device name
- MICROSPEED UNI MOTOR SYSTEM
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-19
- Decision date
- 2006-01-18
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HBC
- Device class
- 2
- Regulation number
- 882.4360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, recall (Z-1474-2011) | Aesculap Inc | 2011-03-02 |