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Codman® 801188

by Integra LifeSciences Production Corporation

Ref 80-1188

Codman® 801188 (80-1188) is a device classified as Class I 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-10381780514770), cleared under FDA 510(k) K851487 on 3 May 1985 and listed in FDA GUDID since 11 May 2020 (UDI-DI 10381780514770), active as of 24 Oct 2026.

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

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K851487

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780514770 Basic UDI-DI 10381780514770UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780514770 UDI-DI Date11 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK851487 Date3 May 1985DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780514770 registered 16 Sep 2026 Active
  • FDA 510(k) K851487 decided 3 May 1985 Active
  • FDA GUDID UDI-DI 10381780514770 listed 11 May 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K851487
  2. Listed FDA GUDID 10381780514770
  3. Registered EUDAMED B-10381780514770

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  • Withdrawn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
Electrical-only medical device connection cable, single-use
Device name
Electro Accessories
Model / Ref / Catalog
80-1188, 801188
Primary DI / UDI-DI
10381780514770
Basic UDI-DI
B-10381780514770
FDA product code
GEI
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Electrical-only medical device connection cable, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 366 Centimeter
Length — 12 Feet

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
80-1188
GUDID
801188
Device classEUDAMED
Class I
GUDID
Class II

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: Electrical-only medical device connection cable, single-use

Cleared under the same submission (K851487)

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

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
Other properties (20, all answered No)