FDA Product Code
FDA Product Code HBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4305
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254177 | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | 2026-09-11 | Traditional | PDF ↗ |
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024-03-06 | Traditional | PDF ↗ |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 | Traditional | PDF ↗ |
| K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | 2019-01-20 | Special | PDF ↗ |
| K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Micromar Ind. Com. , Ltd. | 2015-03-16 | Traditional | PDF ↗ |
| K121253 | MERIDIAN CRANIAL PERFORATOR | Adeor Medical Technologies GmbH | 2012-07-17 | Traditional | PDF ↗ |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | 2008-12-29 | Traditional | PDF ↗ |
| K082637 | CRANIAL PERFORATOR | The Anspach Effort, Inc. | 2008-12-22 | Traditional | PDF ↗ |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | 2008-01-04 | Special | PDF ↗ |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007-10-22 | Traditional | PDF ↗ |
| K032970 | ACRA-CUT XPRESS 120 | Acra Cut, Inc. | 2003-12-08 | Traditional | PDF ↗ |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | The Anspach Effort, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K933894 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-12-10 | Traditional | PDF ↗ |
| K924242 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Acra Cut, Inc. | 1989-06-15 | Traditional | PDF ↗ |
| K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Neurodynamics, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K833266 | ACRA-CUT | Acra Cut, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K820087 | CODMAN * REUSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1982-02-04 | Traditional | PDF ↗ |
| K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON | Codman & Shurtleff, Inc. | 1979-08-28 | Traditional | PDF ↗ |
Product code HBF · Class II · Neurology. Data: openFDA.