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Burr Hole Cover, Model Xx

by Image-Guided Neurologics, Inc.

510(k) K001096

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001096 Date25 Oct 2000ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2228-2021 FDA Class II initiated 2 Jun 2021

    Excess nylon flash on the clip.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXR
Device Class
Class II
Regulation
21 CFR Part 882.5250
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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