Drills, Burrs, Trephines & Accessories (Compound, Powered)
Drills, Burrs, Trephines and Accessories (Compound, Powered) are powered neurosurgical cutting tools with more complex mechanical designs used for advanced skull penetration and bone removal tasks, including those requiring variable speed, torque control, or specialized cutting geometries. They are classified as Class 2 devices (moderate risk), requiring 510(k) premarket notification. The product code is HBF under regulation 21 CFR 882.4305 in the Neurology specialty. These devices are eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HBF
- Device Class
- FDA class 2
- Regulation Number
- 882.4305
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231403 | evoDrill Cranial Perforator | Mar 06, 2024 | Substantially Equivalent | Evonos GmbH & Co. KG |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Jun 20, 2022 | Substantially Equivalent | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. |
| K183581 | Codman Disposable Perforators | Jan 20, 2019 | Substantially Equivalent | Integra Lifesciences Corp. |
| K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Mar 16, 2015 | Substantially Equivalent | Micromar Ind. Com. , Ltd. |
| K121253 | MERIDIAN CRANIAL PERFORATOR | Jul 17, 2012 | Substantially Equivalent | Adeor Medical Technologies GmbH |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Dec 29, 2008 | Substantially Equivalent | Stryker Ireland Ltd., Instruments Division |
| K082637 | CRANIAL PERFORATOR | Dec 22, 2008 | Substantially Equivalent | The Anspach Effort, Inc. |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Jan 04, 2008 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Oct 22, 2007 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K032970 | ACRA-CUT XPRESS 120 | Dec 08, 2003 | Substantially Equivalent | Acra Cut, Inc. |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | Oct 21, 1998 | Substantially Equivalent | The Anspach Effort, Inc. |
| K933894 | DISPOSABLE PERFORATOR | Dec 10, 1993 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K924242 | DISPOSABLE PERFORATOR | Jul 08, 1993 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Jun 15, 1989 | Substantially Equivalent | Acra Cut, Inc. |
| K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Jan 22, 1988 | Substantially Equivalent | Neurodynamics, Inc. |
| K833266 | ACRA-CUT | Dec 29, 1983 | Substantially Equivalent | Acra Cut, Inc. |
| K820087 | CODMAN * REUSABLE PERFORATOR | Feb 04, 1982 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON | Aug 28, 1979 | Substantially Equivalent | Codman & Shurtleff, Inc. |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.