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Codman® 245403

by Integra LifeSciences Production Corporation

Codman 245403 (24-5403) is a neurosurgical sponge (FDA Class II; FDA product code HBA, Neurosurgical paddie) made by Integra LifeSciences Production Corporation, cleared under FDA 510(k) K880402 on 2 Mar 1988 and listed in FDA GUDID since 28 Feb 2020 (UDI-DI 10381780513360), active as of 23 Oct 2026. 3 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

None ongoing

3 closed

Documents

510(k) K880402

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780513360 UDI-DI Date28 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK880402 Date2 Mar 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K880402 decided 2 Mar 1988 Active
  • FDA GUDID UDI-DI 10381780513360 listed 28 Feb 2020 Listed

Recalls

3 recalls · FDA

  • 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

5 dated events

  1. Cleared FDA 510(k) K880402
  2. Recall initiated FDA recalls Z-0094-2011
  3. Recall initiated FDA recalls Z-0095-2011
  4. Recall initiated FDA recalls Z-0093-2011
  5. Listed FDA GUDID 10381780513360

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  • Withdrawn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
245403, 24-5403
Primary DI / UDI-DI
10381780513360
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
Sterilisation method
Ethylene Oxide

Related devices

Category: Neurosurgical sponge

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

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)