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Contour-Flex Valve and Shunt System

by Integra Neurosciences Implants S.A.

510(k) K033698

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK033698 Date17 Dec 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2905-2016 FDA Class II initiated 23 Aug 2016

    During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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