K892866 is an FDA 510(k) clearance for the AUTOMATIC CRANIAL DRILL (PERFORATOR). This device is classified as a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II - Special Controls, product code HBF).
Submitted by Acra Cut, Inc. (Acton, US). The FDA issued a Cleared decision on June 15, 1989, 57 days after receiving the submission on April 19, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K892866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1989 |
| Decision Date | June 15, 1989 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBF — Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4305 |