HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered) Class II
FDA product code HBF covers "Drills, Burrs, Trephines & Accessories (Compound, Powered)", a Class II medical device regulated under 21 CFR 882.4305. Submissions are reviewed by the Neurology panel. At least 18 recent 510(k) clearances have been granted under this product code.
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 |