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Codman Surgical Patties & Strips

by Integra Lifesciences Corporation

510(k) K193346

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

23 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193346 Date20 Nov 2020ClearedStatusActive

Recalls

23 recalls · 23 ongoing · FDA

  • 22 recalls, same reason

    • Ongoing Z-0256-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0255-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0237-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0252-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0238-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0241-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0251-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0253-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0254-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0243-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0240-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0250-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0236-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0244-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0242-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0239-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0245-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0249-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0248-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0235-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0247-2025 FDA Class II initiated 20 Sep 2024
    • Ongoing Z-0246-2025 FDA Class II initiated 20 Sep 2024

    Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

    • Ongoing Z-0909-2023 FDA Class II initiated 2 Dec 2022

    Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

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
HBA
Device Class
Class II
Regulation
21 CFR Part 882.4700
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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