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DURAFORM Dural Graft Implant

by Codman & Shurtleff, Inc.

510(k) K152481

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK152481 Date30 Oct 2015ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0262-2025 FDA Class II initiated 26 Sep 2024

    Out of specification endotoxin levels.

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  • Withdrawn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
GXQ
Device Class
Class II
Regulation
21 CFR Part 882.5910
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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