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CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM - 82-1730

by Codman & Shurtleff, Inc.

510(k) K061568

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 · Special NumberK061568 Date29 Sep 2006ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0090-2015 FDA Class II initiated 15 Sep 2014
    • Terminated Z-0089-2015 FDA Class II initiated 15 Sep 2014
    • Terminated Z-0091-2015 FDA Class II initiated 15 Sep 2014

    tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

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  • Withdrawn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
JXG
Models / Variants
82-1730
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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