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Hermetic™ INS5010

by Integra Lifesciences Corp.

Ref INS5010

Hermetic™ INS5010 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-10381780071082), cleared under FDA 510(k) K972994 on 3 Nov 1997 (2 earlier submissions) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780071082), 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) K972994

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780071082 Basic UDI-DI 10381780071082UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780071082 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-10381780071082 registered 6 Oct 2026 Active
  • FDA 510(k) K972994 decided 3 Nov 1997 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10381780071082 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 10381780071082
  5. Registered EUDAMED B-10381780071082

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  • Withdrawn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
Lumbar cerebrospinal fluid drainage catheterization kit
Device name
Ventricular and Lumbar Catheter Set
Model / Ref / Catalog
INS5010
Primary DI / UDI-DI
10381780071082
Basic UDI-DI
B-10381780071082
510(k) Number
FDA product code
JXG
EMDN code
A060199 Surgical drainage systems - other
GMDN term
Lumbar cerebrospinal fluid drainage catheterization kit
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Lumbar cerebrospinal fluid drainage catheterization kit

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 SURGICAL DRAINAGE SYSTEMS - OTHER.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

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