Cranial Perforator
FDA 510(k) K082637 · The Anspach Effort, Inc.
510(k) numberK082637
Submission
- Device name
- Cranial Perforator
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- September 10, 2008
- Decision date
- December 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K254177 | Disposable Sterile Skull Drill (LZ)HBF · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
| K231403 | evoDrill Cranial PerforatorHBF · Traditional | Evonos GmbH & Co. KG | 03/06/2024SE |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson endHBF · Traditional | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 06/20/2022SE |
| K183581 | Codman Disposable PerforatorsHBF · Special | Integra Lifesciences Corp. | 01/20/2019SE |
| K141455 | Easydrill Autostop Cranial PerforatorHBF · Traditional | Micromar Ind. Com. , Ltd. | 03/16/2015SE |
| K121253 | Meridian Cranial PerforatorHBF · Traditional | Adeor Medical Technologies GmbH | 07/17/2012SE |
| K082010 | Stryker Disposable Cranial Perforator BitHBF · Traditional | Stryker Ireland Ltd., Instruments Division | 12/29/2008SE |
| K073336 | Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231HBF · Special | Codman & Shurtleff, Inc. | 01/04/2008SE |
| K071931 | Codman Disposable Perforator, Model(S) 26-1222, 26-1223HBF · Traditional | Codman & Shurtleff, Inc. | 10/22/2007SE |
| K032970 | Acra-Cut Xpress 120HBF · Traditional | Acra Cut, Inc. | 12/08/2003SE |
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| 510(k) | Device | Decision |
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| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…HBC · Traditional | 05/19/2022SE |
| K183545 | Anspach Helix Dissection ToolsHBE · Traditional | 07/19/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | 03/27/2018SE |
| K133604 | Anspach EG1 High Speed System, G1 AttachmentsHBC · Special | 01/10/2014SE |
| K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemERL · Traditional | 12/31/2013SE |
| K113476 | Anspach Dissection ToolsHBE · Special | 12/16/2011SE |
| K080802 | Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP…HBE · Special | 04/30/2008SE |
| K061297 | Anspach Imri Safe Surgical Drill SystemHBB · Traditional | 01/26/2007SE |
| K063688 | Surgical Irrigation System, Irrigation TubeHWE · Special | 01/16/2007SE |
| K052572 | Anspach Knotless AnchorMBI · Traditional | 12/05/2005SE |
Questions and answers
When was Cranial Perforator cleared by the FDA?
Cranial Perforator (K082637) received a 510(k) decision of Substantially Equivalent on December 22, 2008, 103 days after the submission was received.
What is the product code of K082637?
The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.