Anspach Helix Dissection Tools
FDA 510(k) K183545 · The Anspach Effort, Inc.
510(k) numberK183545
Submission
- Device name
- Anspach Helix Dissection Tools
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- December 20, 2018
- Decision date
- July 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K232684 | Surgify HaloHBE · Traditional | Surgify Medical OY | 11/29/2023SE |
| K230619 | Hubly Electric Drill (H100)HBE · Traditional | Hubly, Inc. | 05/04/2023SE |
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| 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 |
| K082637 | Cranial PerforatorHBF · Traditional | 12/22/2008SE |
| 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 |
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Questions and answers
When was Anspach Helix Dissection Tools cleared by the FDA?
Anspach Helix Dissection Tools (K183545) received a 510(k) decision of Substantially Equivalent on July 19, 2019, 211 days after the submission was received.
What is the product code of K183545?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.