GuardianTM Burr Hole Cover System
FDA 510(k) K181382 · St Jude Medical
510(k) numberK181382
Submission
- Device name
- GuardianTM Burr Hole Cover System
- Applicant
- St Jude Medical
Plano, TX, US - Received
- May 25, 2018
- Decision date
- July 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
| 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 |
| K141368 | Neuropace Burr Hole CoverGXR · Special | NeuroPace, Inc. | 07/11/2014SE |
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| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…DRF · Traditional | 12/13/2016SE |
| K160218 | AutoMark ModuleDQK · Traditional | 12/13/2016SE |
| K160210 | EnSite Precision Cardiac Mapping System v2.0DQK · Traditional | 12/13/2016SE |
| K161873 | Pacel Flow Directed Pacing CatheterLDF · Traditional | 11/22/2016SE |
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Questions and answers
When was GuardianTM Burr Hole Cover System cleared by the FDA?
GuardianTM Burr Hole Cover System (K181382) received a 510(k) decision of Substantially Equivalent on July 20, 2018, 56 days after the submission was received.
What is the product code of K181382?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.