Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4305](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4305) → HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered) # HBF · Drills, Burrs, Trephines & Accessories (Compound, Powered) _Neurology · 21 CFR 882.4305 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF ## Overview - **Product Code:** HBF - **Device Name:** Drills, Burrs, Trephines & Accessories (Compound, Powered) - **Regulation:** [21 CFR 882.4305](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4305) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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). ## Recent Cleared Devices (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K231403](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K231403.md) | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | Mar 6, 2024 | SESE | | [K213228](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K213228.md) | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | Jun 20, 2022 | SESE | | [K183581](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K183581.md) | Codman Disposable Perforators | Integra Lifesciences Corp. | Jan 20, 2019 | SESE | | [K141455](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K141455.md) | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Micromar Ind. Com. , Ltd. | Mar 16, 2015 | SESE | | [K121253](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K121253.md) | MERIDIAN CRANIAL PERFORATOR | Adeor Medical Technologies GmbH | Jul 17, 2012 | SESE | | [K082010](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K082010.md) | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | Dec 29, 2008 | SESE | | [K082637](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K082637.md) | CRANIAL PERFORATOR | The Anspach Effort, Inc. | Dec 22, 2008 | SESE | | [K073336](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K073336.md) | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | Jan 4, 2008 | SESE | | [K071931](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K071931.md) | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | Oct 22, 2007 | SESE | | [K032970](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K032970.md) | ACRA-CUT XPRESS 120 | Acra Cut, Inc. | Dec 8, 2003 | SESE | | [K982991](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K982991.md) | ANSPACH ACCESS CRANIAL PERFORATOR | The Anspach Effort, Inc. | Oct 21, 1998 | SESE | | [K933894](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K933894.md) | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | Dec 10, 1993 | SESE | | [K924242](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K924242.md) | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | Jul 8, 1993 | SESE | | [K892866](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K892866.md) | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Acra Cut, Inc. | Jun 15, 1989 | SESE | | [K875019](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K875019.md) | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Neurodynamics, Inc. | Jan 22, 1988 | SESE | | [K833266](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K833266.md) | ACRA-CUT | Acra Cut, Inc. | Dec 29, 1983 | SESE | | [K820087](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K820087.md) | CODMAN * REUSABLE PERFORATOR | Codman & Shurtleff, Inc. | Feb 4, 1982 | SESE | | [K791101](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF/K791101.md) | 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 - Adeor Medical Technologies GmbH — 1 clearance - Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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