Codman Duraform Dural Graft Implant
FDA 510(k) K041518 · Codman & Shurtleff, Inc.
510(k) numberK041518
Submission
- Device name
- Codman Duraform Dural Graft Implant
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- June 7, 2004
- Decision date
- June 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
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| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | LeMaitre Vascular, Inc. | 06/13/2019SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 11/27/2017SE |
| K163456 | DuraGen Secure Dural Regeneration MatrixGXQ · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 11/02/2016SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 03/16/2016SE |
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| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
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Questions and answers
When was Codman Duraform Dural Graft Implant cleared by the FDA?
Codman Duraform Dural Graft Implant (K041518) received a 510(k) decision of Substantially Equivalent on June 22, 2004, 15 days after the submission was received.
What is the product code of K041518?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.