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Codman® 826884

by Integra LifeSciences Switzerland Sàrl

Part of a family of 8 devices: see the family page

Ref 82-6884

Codman® 826884 (82-6884) is a device classified as Class I in the EU and Class II in the US made by Integra LifeSciences Switzerland Sàrl, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI 038178B0066CSS4E), cleared under FDA 510(k) K152670 on 22 Jan 2016 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780520757), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152670

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/MDR EUDAMED Number038178B0066CSS4E Basic UDI-DI 10381780520757UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780520757 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152670 Date22 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038178B0066CSS4E registered 26 Jun 2026 Active
  • FDA 510(k) K152670 decided 22 Jan 2016 Active
  • FDA GUDID UDI-DI 10381780520757 listed 1 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152670
  2. Listed FDA GUDID 10381780520757
  3. Registered EUDAMED 038178B0066CSS4E

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Codman®
Generic name
Intracranial pressure monitor
Device name
Patient Monitor Interface Cables
Model / Ref / Catalog
82-6884, 826884
Primary DI / UDI-DI
10381780520757
Basic UDI-DI
038178B0066CSS4E
510(k) Number
FDA product code
GWM
EMDN code
Z12109006 Brain tissue monitoring systems
GMDN term
Intracranial pressure monitor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1620
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
82-6884
GUDID
826884
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10381780520757: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I 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: Intracranial pressure monitor

Cleared under the same submission (K152670)

and 6 more cleared under K152670

Similar devices in this category

Other devices filed under VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS.

Other devices from Integra LifeSciences Switzerland Sàrl

See all devices from Integra LifeSciences Switzerland Sàrl →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)