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Codman® 826614

by Integra LifeSciences Production Corporation

Codman® 826614 (82-6614) is a Class II device made by Integra LifeSciences Production Corporation, cleared under FDA 510(k) K914479 on 7 Mar 1994 and listed in FDA GUDID since 28 Feb 2020 (UDI-DI 10381780520375), 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

1 ongoing

This device is named in the recall

Documents

510(k) K914479

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 Number10381780520375 UDI-DI Date28 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK914479 Date7 Mar 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K914479 decided 7 Mar 1994 Active
  • FDA GUDID UDI-DI 10381780520375 listed 28 Feb 2020 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-1614-2023 FDA Class II initiated 11 Apr 2023

    Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

  • 2 recalls, same reason

    • Terminated Z-0706-2012 FDA Unclassified (pre-2012) initiated 25 Oct 2011
    • Terminated Z-0707-2012 FDA Unclassified (pre-2012) initiated 25 Oct 2011

    Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.

Timeline

5 dated events

  1. Cleared FDA 510(k) K914479
  2. Recall initiated FDA recalls Z-0706-2012
  3. Recall initiated FDA recalls Z-0707-2012
  4. Listed FDA GUDID 10381780520375
  5. Recall initiated FDA recalls Z-1614-2023

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  • Withdrawn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
Intracerebral catheter cranial-fixation kit
Model / Ref / Catalog
826614, 82-6614
Primary DI / UDI-DI
10381780520375
510(k) Number
FDA product code
GWM
GMDN term
Intracerebral catheter cranial-fixation kit
Device class
Class II
Regulation number
882.1620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intracerebral catheter cranial-fixation kit

Cleared under the same submission (K914479)

and 6 more cleared under K914479

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)