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Codman EDS3 CSF External Drainage System

by Codman & Shurtleff, Inc. 510(k)

Active United States Open recall

510(k) K162437

Regulatory status

as of 28 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162437 Date28 Oct 2016ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0635-2024 FDA Class II initiated 28 Nov 2023
    • Ongoing Z-0634-2024 FDA Class II initiated 28 Nov 2023

    Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

    • Terminated Z-1143-2021 FDA Class II initiated 12 Jan 2021

    The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

Specification

510(k)

510(k) Number
FDA Product Code
JXG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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