Shelhigh No-React Dura Shield
FDA 510(k) K982101 · Shelhigh, Inc.
510(k) numberK982101
Submission
- Device name
- Shelhigh No-React Dura Shield
- Applicant
- Shelhigh, Inc.
Millburn, NJ, US - Received
- June 15, 1998
- Decision date
- May 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | Collagen Matrix, Inc. | 11/18/2025SE |
| K250420 | Helios Dura Regeneration MatrixGXQ · Traditional | Helios Biomedical, Inc. | 05/14/2025SE |
| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | Synthes (USA) Products, LLC | 01/28/2022SE |
| 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 |
More from Acera Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032893 | Shelhigh No-React BiocuffFTL · Traditional | 12/19/2003SE |
| K023940 | Shelhigh BioringKRH · Traditional | 06/04/2003SE |
| K991567 | Shelhigh No-React Tissue Repair Patch/Uropatch.FTM · Traditional | 07/14/1999SE |
| K982810 | Shelhigh No-React VascupatchDXZ · Traditional | 10/28/1998SE |
| K981756 | Shelhigh No-React PneumopledgetsFTL · Traditional | 08/05/1998SE |
| K974914 | Shelhigh No-React Pericardial PatchesDXZ · Traditional | 06/03/1998SE |
| K964467 | Shelhigh Pericardial PatchDXZ · Traditional | 09/23/1997SE |
Questions and answers
When was Shelhigh No-React Dura Shield cleared by the FDA?
Shelhigh No-React Dura Shield (K982101) received a 510(k) decision of Substantially Equivalent on May 2, 2000, 687 days after the submission was received.
What is the product code of K982101?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.