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LimiTorr™ INS9020SP1

by Integra Lifesciences Corp.

LimiTorr™ INS9020SP1 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K191684 on 11 Oct 2019 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2015 (UDI-DI 10381780071112), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191684 Date11 Oct 2019DecidedStatusActive
United StatesGUDID listing Number10381780071112 UDI-DI Date22 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191684 decided 11 Oct 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780071112 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

4 dated events

  1. Cleared FDA 510(k) K072929
  2. Listed FDA GUDID 10381780071112
  3. Recall initiated FDA recalls Z-1312-2019
  4. Cleared FDA 510(k) K191684

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LimiTorr™
Generic name
Ventricular cerebrospinal fluid drainage catheterization kit
Model / Ref / Catalog
INS9020SP1
Primary DI / UDI-DI
10381780071112
510(k) Number
FDA product code
JXG
GMDN term
Ventricular cerebrospinal fluid drainage catheterization kit
Device class
Class II
Regulation number
882.5550
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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

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 (9, all answered No)