HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered) Class II
FDA Device Classification
Classification Details
- Product Code
- HBF
- Device Class
- Class II
- Regulation Number
- 882.4305
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231403 | evonos gmbh and co. kg | evoDrill Cranial Perforator | March 6, 2024 |
| K213228 | emd endoszkop muszer gyarto es kereskedelmi kft | NeuroLine Disposable Cranial Perforator with Hudson end | June 20, 2022 |
| K183581 | integra lifesciences | Codman Disposable Perforators | January 20, 2019 |
| K141455 | micromar ind. com. | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | March 16, 2015 |
| K121253 | adeor medical technologies | MERIDIAN CRANIAL PERFORATOR | July 17, 2012 |
| K082010 | stryker ireland ltd., instruments division | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | December 29, 2008 |
| K082637 | anspach effort | CRANIAL PERFORATOR | December 22, 2008 |
| K073336 | codman and shurtleff | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | January 4, 2008 |
| K071931 | codman and shurtleff | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | October 22, 2007 |
| K032970 | acra cut | ACRA-CUT XPRESS 120 | December 8, 2003 |
| K982991 | anspach effort | ANSPACH ACCESS CRANIAL PERFORATOR | October 21, 1998 |
| K933894 | codman and shurtleff | DISPOSABLE PERFORATOR | December 10, 1993 |
| K924242 | codman and shurtleff | DISPOSABLE PERFORATOR | July 8, 1993 |
| K892866 | acra cut | AUTOMATIC CRANIAL DRILL (PERFORATOR) | June 15, 1989 |
| K875019 | neurodynamics | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | January 22, 1988 |
| K833266 | acra cut | ACRA-CUT | December 29, 1983 |
| K820087 | codman and shurtleff | CODMAN * REUSABLE PERFORATOR | February 4, 1982 |
| K791101 | codman and shurtleff | DISPOSABLE PERFORATORS, JACOBS, HUDSON | August 28, 1979 |