Product code HBF
- Device name
- Drills, Burrs, Trephines & Accessories (Compound, Powered)
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4305
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024-03-06 |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 |
| K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | 2019-01-20 |
| K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Micromar Ind. Com. , Ltd. | 2015-03-16 |
| K121253 | MERIDIAN CRANIAL PERFORATOR | Adeor Medical Technologies GmbH | 2012-07-17 |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | 2008-12-29 |
| K082637 | CRANIAL PERFORATOR | The Anspach Effort, Inc. | 2008-12-22 |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | 2008-01-04 |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007-10-22 |
| K032970 | ACRA-CUT XPRESS 120 | Acra Cut, Inc. | 2003-12-08 |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | The Anspach Effort, Inc. | 1998-10-21 |
| K933894 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-12-10 |
| K924242 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-07-08 |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Acra Cut, Inc. | 1989-06-15 |
| K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Neurodynamics, Inc. | 1988-01-22 |
| K833266 | ACRA-CUT | Acra Cut, Inc. | 1983-12-29 |
| K820087 | CODMAN * REUSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1982-02-04 |
| K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON | Codman & Shurtleff, Inc. | 1979-08-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07898959543326 | EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm | Micromar Indústria e Comércio Ltda | 2019-07-24 |
| 07898959543333 | EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm | Micromar Indústria e Comércio Ltda | 2019-07-24 |
| 07898959543340 | EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm | Micromar Indústria e Comércio Ltda | 2019-07-24 |
| 07898959543357 | EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm | Micromar Indústria e Comércio Ltda | 2019-07-24 |
| 00845384002055 | NA | Synthes GmbH | 2018-02-05 |
| 00845384004233 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003489 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003717 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003731 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003748 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003915 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003922 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384004059 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384004219 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003250 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384004240 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384004462 | NA | Synthes GmbH | 2016-09-09 |
| 00845384004707 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003335 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003328 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003236 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003144 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003106 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384003021 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384002994 | NA | Anspach Effort, The | 2016-09-09 |
| 00845384002857 | NA | Anspach Effort, The | 2016-09-09 |
| 07898959543050 | EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm | Micromar Indústria e Comércio Ltda | 2016-08-19 |
| 07898959543081 | EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm | Micromar Indústria e Comércio Ltda | 2016-08-19 |
| 07898959543074 | EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mm | Micromar Indústria e Comércio Ltda | 2016-08-19 |
| 07898959543067 | EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm | Micromar Indústria e Comércio Ltda | 2016-08-19 |