K061297 is an FDA 510(k) clearance for the ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 26, 2007, 262 days after receiving the submission on May 9, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K061297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2006 |
| Decision Date | January 26, 2007 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |