HBF · Drills, Burrs, Trephines & Accessories (Compound, Powered)
Neurology · 21 CFR 882.4305 · Class 2
Overview
| Product Code | HBF |
|---|---|
| Device Name | Drills, Burrs, Trephines & Accessories (Compound, Powered) |
| Regulation | 21 CFR 882.4305 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | Mar 6, 2024 | SESE |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | Jun 20, 2022 | SESE |
| K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | Jan 20, 2019 | SESE |
| K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Micromar Ind. Com. , Ltd. | Mar 16, 2015 | SESE |
| K121253 | MERIDIAN CRANIAL PERFORATOR | Adeor Medical Technologies GmbH | Jul 17, 2012 | SESE |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | Dec 29, 2008 | SESE |
| K082637 | CRANIAL PERFORATOR | The Anspach Effort, Inc. | Dec 22, 2008 | SESE |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | Jan 4, 2008 | SESE |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | Oct 22, 2007 | SESE |
| K032970 | ACRA-CUT XPRESS 120 | Acra Cut, Inc. | Dec 8, 2003 | SESE |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | The Anspach Effort, Inc. | Oct 21, 1998 | SESE |
| K933894 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | Dec 10, 1993 | SESE |
| K924242 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | Jul 8, 1993 | SESE |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Acra Cut, Inc. | Jun 15, 1989 | SESE |
| K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Neurodynamics, Inc. | Jan 22, 1988 | SESE |
| K833266 | ACRA-CUT | Acra Cut, Inc. | Dec 29, 1983 | SESE |
| K820087 | CODMAN * REUSABLE PERFORATOR | Codman & Shurtleff, Inc. | Feb 4, 1982 | SESE |
| K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON | Codman & Shurtleff, Inc. | Aug 28, 1979 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 6 clearances
- Acra Cut, Inc. — 3 clearances
- The Anspach Effort, Inc. — 2 clearances
- Stryker Ireland Ltd., Instruments Division — 1 clearance
- Neurodynamics, Inc. — 1 clearance
