Acra-Cut
FDA 510(k) K833266 · Acra Cut, Inc.
510(k) numberK833266
Submission
- Device name
- Acra-Cut
- Applicant
- Acra Cut, Inc.
Acton, MA, US - Received
- September 21, 1983
- Decision date
- December 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HBF
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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 |
| K082637 | Cranial PerforatorHBF · Traditional | The Anspach Effort, Inc. | 12/22/2008SE |
| 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 |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032970 | Acra-Cut Xpress 120HBF · Traditional | 12/08/2003SE |
| K944311 | Acra-CutHBO · Traditional | 11/18/1994SE |
| K911819 | Acra-Cut Neurological Surgical Device-PoweredHBE · Traditional | 09/10/1991SE |
| K911812 | Acra-Cut Wire Pass DrillHBE · Traditional | 09/10/1991SE |
| K910226 | Dural DissectorsHAO · Traditional | 02/12/1991SE |
| K910225 | Bone Pad RemoverHAO · Traditional | 02/12/1991SE |
| K892866 | Automatic Cranial Drill (Perforator)HBF · Traditional | 06/15/1989SE |
Questions and answers
When was Acra-Cut cleared by the FDA?
Acra-Cut (K833266) received a 510(k) decision of Substantially Equivalent on December 29, 1983, 99 days after the submission was received.
What is the product code of K833266?
The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.