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Hermetic™ INS301

by Integra Lifesciences Corp.

Part of a family of 6 devices: see the family page

Ref INS301

Hermetic™ INS301 is a device classified as Class I in the EU and Class II in the US made by Integra Lifesciences Corp., registered in EUDAMED on 7 Jul 2026 (Basic UDI-DI 038178B0020CSSZM), cleared under FDA 510(k) K062599 on 27 Sep 2006 and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780112174), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K062599

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038178B0020CSSZM Basic UDI-DI 10381780112174UDI-DIDate7 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780112174 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK062599 Date27 Sep 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038178B0020CSSZM registered 7 Jul 2026 Active
  • FDA 510(k) K062599 decided 27 Sep 2006 Active
  • FDA GUDID UDI-DI 10381780112174 listed 22 Sep 2015 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1310-2019 FDA Class I initiated 8 Apr 2019
    • Terminated Z-1311-2019 FDA Class I initiated 8 Apr 2019

    The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Timeline

5 dated events

  1. Cleared FDA 510(k) K062599
  2. Listed FDA GUDID 10381780112174
  3. Recall initiated FDA recalls Z-1310-2019
  4. Recall initiated FDA recalls Z-1311-2019
  5. Registered EUDAMED 038178B0020CSSZM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Integra® EUDAMED
Hermetic™ GUDID
Generic name
Frame/rail/pole device holder
Device name
Pole Mount Assemblies
Model / Ref / Catalog
INS301
Primary DI / UDI-DI
10381780112174
Basic UDI-DI
038178B0020CSSZM
510(k) Number
FDA product code
JXG
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Frame/rail/pole device holder
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5550
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Frame/rail/pole device holder

Cleared under the same submission (K062599)

and 8 more cleared under K062599

Similar devices in this category

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

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)