Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
FDA 510(k) K152342 · St Jude Medical
510(k) numberK152342
Submission
- Device name
- Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
- Applicant
- St Jude Medical
Plano, TX, US - Received
- August 19, 2015
- Decision date
- June 9, 2016
- 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 |
| K140309 | CranioplugGXR · Traditional | Ossdsign AB | 10/03/2014SE |
| K141368 | Neuropace Burr Hole CoverGXR · Special | NeuroPace, Inc. | 07/11/2014SE |
More from NeuroPace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181382 | GuardianTM Burr Hole Cover SystemGXR · Abbreviated | 07/20/2018SE |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2DQK · Traditional | 04/23/2018SE |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledMTD · Traditional | 04/23/2018SE |
| K173232 | myMerlin(TM) Mobile Application Model APP1001MXC · Special | 11/02/2017SE |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC · Traditional | 09/29/2017SE |
| K162643 | MediGuide Technology SystemDQK · Traditional | 12/13/2016SE |
| 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 |
Questions and answers
When was Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover cleared by the FDA?
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342) received a 510(k) decision of Substantially Equivalent on June 9, 2016, 295 days after the submission was received.
What is the product code of K152342?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.