ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
FDA 510(k) clearance K040186 · decided 2004-04-15
Clearance details
- K-number
- K040186
- Device name
- ANSPACH MRI SAFE SURGICAL DRILL SYSTEM
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-27
- Decision date
- 2004-04-15
- Days to decision
- 79 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
+ Add to Predicate Builder ◉ Watch The Anspach Effort
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be recall (Z-1906-2014) | The Anspach Effort, Inc. | 2014-06-25 |
| ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to recall (Z-1907-2014) | The Anspach Effort, Inc. | 2014-06-25 |