DISPOSABLE PERFORATOR
Device Facts
| Record ID | K933894 |
|---|---|
| Device Name | DISPOSABLE PERFORATOR |
| Applicant | Codman & Shurtleff, Inc. |
| Product Code | HBF · Neurology |
| Decision Date | Dec 10, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4305 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.
