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LimiTorr™ INS9020

by Integra Lifesciences Corp.

Ref INS9020

LimiTorr™ INS9020 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 14 Oct 2026 (Basic UDI-DI B-10381780071105), cleared under FDA 510(k) K191684 on 11 Oct 2019 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780071105), active as of 24 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191684

+1 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-10381780071105 Basic UDI-DI 10381780071105UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191684 Date11 Oct 2019DecidedStatusActive
United StatesGUDID listing GUDID Number10381780071105 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780071105 registered 14 Oct 2026 Active
  • FDA 510(k) K191684 decided 11 Oct 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780071105 listed 22 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1312-2019 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) K072929
  2. Listed FDA GUDID 10381780071105
  3. Recall initiated FDA recalls Z-1312-2019
  4. Cleared FDA 510(k) K191684
  5. Registered EUDAMED B-10381780071105

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  • Withdrawn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
LimiTorr™
Generic name
Lumbar cerebrospinal fluid drainage catheterization kit
Device name
MoniTorr ICP, LimiTorr Volume Limiting External CSF Drainage
Model / Ref / Catalog
INS9020
Primary DI / UDI-DI
10381780071105
Basic UDI-DI
B-10381780071105
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 I EUDAMED
Class II GUDID
Regulation number
882.5550
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit

Cleared under the same submission (K072929)

Cleared under the same submission (K191684)

and 8 more cleared under K191684

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
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)