Atlas FDA

GuardianTM Burr Hole Cover System

FDA 510(k) clearance K181382 · decided 2018-07-20

Clearance details

K-number
K181382
Device name
GuardianTM Burr Hole Cover System
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2018-05-25
Decision date
2018-07-20
Days to decision
56 days
Clearance type
Abbreviated
Product code
GXR
Device class
2
Regulation number
882.5250
Medical specialty
Neurology
Advisory committee
Neurology
Location
Plano, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (K253447)Orthocon, Inc.2026-03-16
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (K240137)Neos Surgery S.L2024-02-16
Absorbable Cranial Flap Fixation System (K221606)Chendu Medart Medical Scientific Co., Ltd.2023-11-21
Flap Fixator, Burr Hole Cover (K192310)Ossaware Biotech Co., Ltd.2020-06-03
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate (K192162)Neurovention, LLC2020-03-13
OSSDSIGN Cranioplug (K181539)Ossdsign AB2018-10-12
Cranial COVER (K160739)Neos Surgery S.L2016-06-12
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (K152342)St Jude Medical2016-06-09
CRANIOPLUG (K140309)Ossdsign AB2014-10-03
NEUROPACE BURR HOLE COVER (K141368)NeuroPace, Inc.2014-07-11
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM (K132044)Neos Surgery S.L2013-09-30
TRS CRANIAL BONE VOID FILLER(TRS C-BVF) (K123633)Tissue Regeneration Systems, Inc.2013-08-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S096)St Jude Medical2025-12-23
TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S094)St Jude Medical2025-06-20
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S095)St Jude Medical2025-05-06
Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable (P960016/S092)St Jude Medical2025-04-10
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S093)St Jude Medical2025-04-10
TactiCath Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S092)St Jude Medical2024-11-27
TactiCath Ablation Catheter, Sensor Enabled (P130026/S091)St Jude Medical2024-11-22
TactiCath Contact Force Ablation Catheter (P130026/S090)St Jude Medical2024-10-09