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Codman® 801398

by Integra LifeSciences Production Corporation

Codman 801398 (80-1398) is a neurosurgical sponge (FDA Class II; FDA product code HBA, Neurosurgical paddie) made by Integra LifeSciences Production Corporation, cleared under FDA 510(k) K193346 on 20 Nov 2020 (1 earlier submission) and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780514947), active as of 23 Oct 2026. 26 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193346 Date20 Nov 2020DecidedStatusActive
United StatesGUDID listing Number10381780514947 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193346 decided 20 Nov 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780514947 listed 1 Apr 2020 Listed

Recalls

26 recalls · 23 ongoing · FDA

  • 22 recalls, same reason

    • Ongoing Z-0238-2025 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-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
    • Ongoing Z-0256-2025 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

    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.

  • 2 recalls, same reason

    • Terminated Z-0094-2011 FDA Unclassified (pre-2012) initiated 16 Jul 2010
    • Terminated Z-0093-2011 FDA Unclassified (pre-2012) initiated 16 Jul 2010

    Surgical Pattie x-ray stripe (radio-opaque marker) became detached

    • Terminated Z-0095-2011 FDA Unclassified (pre-2012) initiated 16 Jul 2010

    Surgical Pattie x-ray stripe (radio-opaque marker) may become detached

Timeline

29 dated events

  1. Recall initiated FDA recalls Z-0243-2025
  2. Recall initiated FDA recalls Z-0240-2025
  3. Recall initiated FDA recalls Z-0250-2025
  4. Recall initiated FDA recalls Z-0236-2025
  5. Recall initiated FDA recalls Z-0244-2025
  6. Recall initiated FDA recalls Z-0242-2025
  7. Recall initiated FDA recalls Z-0239-2025
  8. Recall initiated FDA recalls Z-0245-2025
  9. Recall initiated FDA recalls Z-0249-2025
  10. Recall initiated FDA recalls Z-0248-2025

19 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Codman®
Generic name
Neurosurgical sponge
Model / Ref / Catalog
801398, 80-1398
Primary DI / UDI-DI
10381780514947
510(k) Number
FDA product code
HBA
GMDN term
Neurosurgical sponge
Device class
Class II
Regulation number
882.4700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neurosurgical sponge

Cleared under the same submission (K193346)

and 8 more cleared under K193346

Cleared under the same submission (K880402)

and 8 more cleared under K880402

Similar devices

Other devices filed under FDA product code HBA (Neurosurgical paddie).

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)