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Integra® NL8500200

by Integra Lifesciences Corp.

Ref NL8500200

Integra® NL8500200 is a device classified as Class III in the EU and Class II in the US made by Integra Lifesciences Corp., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-10381780024156), cleared under FDA 510(k) K153041 on 14 Mar 2016 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780024156), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153041

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780024156 Basic UDI-DI 10381780024156UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153041 Date14 Mar 2016DecidedStatusActive
United StatesGUDID listing GUDID Number10381780024156 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780024156 registered 6 Oct 2026 Active
  • FDA 510(k) K153041 decided 14 Mar 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780024156 listed 22 Sep 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K760785
  2. Listed FDA GUDID 10381780024156
  3. Cleared FDA 510(k) K153041
  4. Registered EUDAMED B-10381780024156

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  • Withdrawn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
Integra Anti-Siphon Device EUDAMED
Integra® GUDID
Generic name
Cerebrospinal fluid shunt valve
Device name
CSF Drainage Systems
Model / Ref / Catalog
NL8500200
Primary DI / UDI-DI
10381780024156
Basic UDI-DI
B-10381780024156
510(k) Number
FDA product code
JXG
EMDN code
C0180 Artero-venous system devices - accessories not included in other classes
GMDN term
Cerebrospinal fluid shunt valve
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Cerebrospinal fluid shunt valve

Cleared under the same submission (K153041)

and 8 more cleared under K153041

Similar devices in this category

Other devices filed under ARTERIO-VENOUS SYSTEM DEVICES.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

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