Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter, Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit

• • Ongoing Z-1036-2026 FDA Class II ·initiated 12 Dec 2025

  Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

510(k) Number

K153347 ↗

FDA Product Code

GWM

Device Class

Class II

Regulation

21 CFR Part 882.1620

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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