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Hermetic™ INS4000

by Integra Lifesciences Corp.

Ref INS4000

Hermetic™ INS4000 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-10381780071068), cleared under FDA 510(k) K972994 on 3 Nov 1997 (2 earlier submissions) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780071068), 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) K972994

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780071068 Basic UDI-DI 10381780071068UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780071068 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972994 Date3 Nov 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780071068 registered 6 Oct 2026 Active
  • FDA 510(k) K972994 decided 3 Nov 1997 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10381780071068 listed 22 Sep 2015 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K820247
  2. Cleared FDA 510(k) K970658
  3. Cleared FDA 510(k) K972994
  4. Listed FDA GUDID 10381780071068
  5. Registered EUDAMED B-10381780071068

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  • Withdrawn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
Hermetic™
Generic name
Intracerebral infusion/drainage catheter, long-term
Device name
Ventricular and Lumbar Catheter Set
Model / Ref / Catalog
INS4000
Primary DI / UDI-DI
10381780071068
Basic UDI-DI
B-10381780071068
510(k) Number
FDA product code
JXG
EMDN code
A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
GMDN term
Intracerebral infusion/drainage catheter, long-term
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

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: Intracerebral infusion/drainage catheter, long-term

Cleared under the same submission (K820247)

and 3 more cleared under K820247

Cleared under the same submission (K970658)

and 4 more cleared under K970658

Similar devices in this category

Other devices filed under EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS).

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)