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Codman Quad-Lock Sterilization Container System

by Codman & Shurtleff, Inc. 510(k)

Active United States

510(k) K120117

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120117 Date16 Apr 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0833-2014 FDA Class II initiated 5 Dec 2013

    The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.

Specification

510(k)

510(k) Number
FDA Product Code
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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