Home / 510(k) Clearances / K152342

510(k) K152342

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover by St Jude Medical — Product Code GXR

K152342 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover". The FDA issued a decision of Substantially Equivalent on June 9, 2016. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. St Jude Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2016
Date Received
August 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

Other clearances by St Jude Medical

  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K172396 — EnSite Velocity Cardiac Mapping System v5.2 (April 23, 2018)
  • K173232 — myMerlin(TM) Mobile Application Model APP1001 (November 2, 2017)
  • K160218 — AutoMark Module (December 13, 2016)
  • K162643 — MediGuide Technology System (December 13, 2016)
  • K160210 — EnSite Precision Cardiac Mapping System v2.0 (December 13, 2016)
  • K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL (December 13, 2016)
  • K161873 — Pacel Flow Directed Pacing Catheter (November 22, 2016)
  • K160187 — Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (October 21, 2016)
  • K160186 — EnSite Velocity Surface Electrode Kit (October 7, 2016)

Other clearances for product code GXR

  • K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (March 16, 2026)
  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221606 — Absorbable Cranial Flap Fixation System (November 21, 2023)
  • K192310 — Flap Fixator, Burr Hole Cover (June 3, 2020)
  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K160739 — Cranial COVER (June 12, 2016)
  • K140309 — CRANIOPLUG (October 3, 2014)
  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)

FDA data resources