Gore Burr Hole Cover
FDA 510(k) K960656 · W. L. Gore & Associates, Inc.
510(k) numberK960656
Submission
- Device name
- Gore Burr Hole Cover
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- February 15, 1996
- Decision date
- August 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXR
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|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional | Orthocon, Inc. | 03/16/2026SE |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special | Neos Surgery S.L | 02/16/2024SE |
| K221606 | Absorbable Cranial Flap Fixation SystemGXR · Traditional | Chendu Medart Medical Scientific Co., Ltd. | 11/21/2023SE |
| K192310 | Flap Fixator, Burr Hole CoverGXR · Traditional | Ossaware Biotech Co., Ltd. | 06/03/2020SE |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional | Neurovention, LLC | 03/13/2020SE |
| K181539 | OSSDSIGN CranioplugGXR · Traditional | Ossdsign AB | 10/12/2018SE |
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | St Jude Medical | 07/20/2018SE |
| K160739 | Cranial COVERGXR · Traditional | Neos Surgery S.L | 06/12/2016SE |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional | St Jude Medical | 06/09/2016SE |
| K140309 | CranioplugGXR · Traditional | Ossdsign AB | 10/03/2014SE |
More from Ossdsign AB
| 510(k) | Device | Decision |
|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
Questions and answers
When was Gore Burr Hole Cover cleared by the FDA?
Gore Burr Hole Cover (K960656) received a 510(k) decision of Substantially Equivalent on August 14, 1996, 181 days after the submission was received.
What is the product code of K960656?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.