Atlas FDA

NEUROPACE BURR HOLE COVER MODEL 8110

FDA 510(k) clearance K123163 · decided 2013-01-18

Clearance details

K-number
K123163
Device name
NEUROPACE BURR HOLE COVER MODEL 8110
Applicant
NeuroPace, Inc.
Decision
Substantially Equivalent
Date received
2012-10-09
Decision date
2013-01-18
Days to decision
101 days
Clearance type
Traditional
Product code
GXR
Device class
2
Regulation number
882.5250
Medical specialty
Neurology
Advisory committee
Neurology
Location
Mountain View, CA, US
Third-party review
No
Expedited review
No

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OSSDSIGN Cranioplug (K181539)Ossdsign AB2018-10-12
GuardianTM Burr Hole Cover System (K181382)St Jude Medical2018-07-20
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CRANIOPLUG (K140309)Ossdsign AB2014-10-03
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
NeuroPace® RNS® System (P100026/S099)NeuroPace, Inc.2025-08-18
NEUROPACE RNS SYSTEM (P100026/S098)NeuroPace, Inc.2025-05-12
NeuroPace Remote Monitor (P100026/S097)NeuroPace, Inc.2024-12-18
NEUROPACE RNS SYSTEM (P100026/S096)NeuroPace, Inc.2024-12-11
NeuroPace RNS System (P100026/S095)NeuroPace, Inc.2024-08-13
NeuroPace® RNS® System (P100026/S087)NeuroPace, Inc.2023-09-28
NeuroPace® RNS® System (P100026/S094)NeuroPace, Inc.2023-08-28
NeuroPace® RNS® System (P100026/S093)NeuroPace, Inc.2023-02-17