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CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit

by Codman & Shurtleff, Inc. 510(k)

Active United States Open recall

510(k) K173192

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK173192 Date8 Nov 2017ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1037-2026 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.

Specification

510(k)

510(k) Number
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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