ASPACH 65,000 (MODIFICATION)
FDA 510(k) clearance K955084 · decided 1996-01-17
Clearance details
- K-number
- K955084
- Device name
- ASPACH 65,000 (MODIFICATION)
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-19
- Decision date
- 1996-01-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HSZ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, inclu recall (Z-1983-2014) | The Anspach Effort, Inc. | 2014-07-03 |
| ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Inten recall (Z-0654-2014) | The Anspach Effort, Inc. | 2014-01-09 |
| Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Sys recall (Z-0199-2014) | The Anspach Effort, Inc. | 2013-11-13 |
| Anspach Single Use, Sterile Bone Cutting Burrs recall (Z-1008-2007) | The Anspach Effort, Inc. | 2007-07-11 |