Atlas FDA

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

FDA 510(k) clearance K152342 · decided 2016-06-09

Clearance details

K-number
K152342
Device name
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
Applicant
St Jude Medical
Decision
Substantially Equivalent
Date received
2015-08-19
Decision date
2016-06-09
Days to decision
295 days
Clearance type
Traditional
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
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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
GuardianTM Burr Hole Cover System (K181382)St Jude Medical2018-07-20
Cranial COVER (K160739)Neos Surgery S.L2016-06-12
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
TactiSys Quartz Equipment; Ampere Generator (P130026/S102)St Jude Medical2026-08-07
Ampere Generator (P960016/S094)St Jude Medical2026-08-07
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P130026/S100)St Jude Medical2026-06-05
TactiCath™ Ablation Catheter, Sensor Enabled™ (TactiCath™ SE) (P130026/S101)St Jude Medical2026-05-29
TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- (P130026/S099)St Jude Medical2026-05-15
TactiCath™ Sensor Enabled™ (P130026/S098)St Jude Medical2026-01-15
Livewire™ TC XLS™ (P960016/S093)St Jude Medical2026-01-15
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) (P130026/S097)St Jude Medical2026-01-08