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CODMAN CRANIOTOMY KIT - 26-1231

by Codman & Shurtleff, Inc.

510(k) K073336

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 NumberK073336 Date4 Jan 2008ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1717-2025 FDA Class I initiated 11 Apr 2025

    Inadequate weld that can potentially cause the product to disassemble.

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  • Withdrawn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
HBF
Models / Variants
26-1231
Device Class
Class II
Regulation
21 CFR Part 882.4305
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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