ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
FDA 510(k) clearance K061297 · decided 2007-01-26
Clearance details
- K-number
- K061297
- Device name
- ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-09
- Decision date
- 2007-01-26
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- HBB
- Device class
- 2
- Regulation number
- 882.4370
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: Th recall (Z-0657-2014) | The Anspach Effort, Inc. | 2014-01-09 |
| .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. recall (Z-2077-2012) | The Anspach Effort, Inc. | 2012-07-25 |
| Anspach Single Use, Sterile Bone Cutting Burrs recall (Z-1008-2007) | The Anspach Effort, Inc. | 2007-07-11 |