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Codman® 826609

by Integra LifeSciences Production Corporation

Ref 82-6609

Codman® 826609 (82-6609) is a device classified as Class IIa in the EU and Class II in the US made by Integra LifeSciences Production Corporation, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-10381780520351), cleared under FDA 510(k) K914479 on 7 Mar 1994 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780520351), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K914479

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780520351 Basic UDI-DI 10381780520351UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780520351 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK914479 Date7 Mar 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780520351 registered 16 Sep 2026 Active
  • FDA 510(k) K914479 decided 7 Mar 1994 Active
  • FDA GUDID UDI-DI 10381780520351 listed 1 Apr 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

6 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 10381780520351
  5. Recall initiated FDA recalls Z-1614-2023
  6. Registered EUDAMED B-10381780520351

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Codman®
Generic name
Manual cranial rotary handpiece, single-use
Device name
Cranial Access
Model / Ref / Catalog
82-6609, 826609
Primary DI / UDI-DI
10381780520351
Basic UDI-DI
B-10381780520351
510(k) Number
FDA product code
GWM
EMDN code
P091304 Cranial perforators, single-use
GMDN term
Manual cranial rotary handpiece, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1620
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
82-6609
GUDID
826609
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Manual cranial rotary handpiece, single-use

Cleared under the same submission (K914479)

and 6 more cleared under K914479

Similar devices in this category

Other devices filed under CRANIAL PERFORATORS, SINGLE-USE.

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 (19, all answered No)