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MoniTorr™ 10100

by Integra Lifesciences Corp.

Ref 10100

MoniTorr™ 10100 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-10381780070825), cleared under FDA 510(k) K191684 on 11 Oct 2019 (3 earlier submissions) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780070825), active as of 24 Oct 2026. 2 FDA recalls are 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191684

+3 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-10381780070825 Basic UDI-DI 10381780070825UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191684 Date11 Oct 2019DecidedStatusActive
United StatesGUDID listing GUDID Number10381780070825 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780070825 registered 14 Oct 2026 Active
  • FDA 510(k) K191684 decided 11 Oct 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10381780070825 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

8 dated events

  1. Cleared FDA 510(k) K920156
  2. Cleared FDA 510(k) K022554
  3. Cleared FDA 510(k) K062599
  4. Listed FDA GUDID 10381780070825
  5. Recall initiated FDA recalls Z-1310-2019
  6. Recall initiated FDA recalls Z-1311-2019
  7. Cleared FDA 510(k) K191684
  8. Registered EUDAMED B-10381780070825

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
MoniTorr™
Generic name
Ventricular cerebrospinal fluid drainage catheterization kit
Device name
MoniTorr ICP, LimiTorr Volume Limiting External CSF Drainage
Model / Ref / Catalog
10100
Primary DI / UDI-DI
10381780070825
Basic UDI-DI
B-10381780070825
510(k) Number
FDA product code
JXG
EMDN code
A060199 Surgical drainage systems - other
GMDN term
Ventricular 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

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 (K022554)

and 8 more cleared under K022554

Cleared under the same submission (K062599)

and 8 more cleared under K062599

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
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)