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Codman® 9190001RP

by Integra LifeSciences Switzerland Sàrl

Ref 9190001RP

Codman® 9190001RP is a device classified as Class IIa in the EU and Class II in the US made by Integra LifeSciences Switzerland Sàrl, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI B-10381780521747), cleared under FDA 510(k) K163106 on 1 Dec 2016 and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780521747), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163106

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780521747 Basic UDI-DI 10381780521747UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780521747 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK163106 Date1 Dec 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780521747 registered 10 Sep 2026 Active
  • FDA 510(k) K163106 decided 1 Dec 2016 Active
  • FDA GUDID UDI-DI 10381780521747 listed 1 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163106
  2. Listed FDA GUDID 10381780521747
  3. Registered EUDAMED B-10381780521747

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  • Withdrawn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
Model / Ref / Catalog
9190001RP
Primary DI / UDI-DI
10381780521747
Basic UDI-DI
B-10381780521747
510(k) Number
FDA product code
GEI
EMDN code
A03040299 Irrigation kits, single-use - other
GMDN term
Electrical-only medical device connection cable, single-use
Device class
Class IIa 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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Electrical-only medical device connection cable, single-useSurgical irrigation tubing set, single-use

Cleared under the same submission (K163106)

and 2 more cleared under K163106

Similar devices in this category

Other devices filed under IRRIGATION KITS, SINGLE-USE - OTHER.

Other devices from Integra LifeSciences Switzerland Sàrl

See all devices from Integra LifeSciences Switzerland Sàrl →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)