Skip to content

Integra Neurosciences

Also registered as Integra Neurosciences, Ltd.

United Statesfrom the FDA registration address FDA establishment FEI 3000204775

Devices
9
Registrations
FDA
FDA recalls
5

What Integra Neurosciences makes

The company manufactures intracranial monitoring devices, including cortical surface electrodes for brain activity recording, intracranial pressure (ICP) monitoring catheters, and related monitoring systems like the LICOX and CAMINO series for cerebral oxygenation and pressure assessment. It also produces an ultrasonic surgical aspirator for neurosurgical procedures and external cerebrospinal fluid (CSF) drainage systems paired with monitoring capabilities. Additional offerings include microprobes for brain oxygen measurement and standalone ICP monitoring kits.

These devices are classified under FDA Class II and Class U, with regulatory submissions documented via 510(k) clearances. The portfolio is listed in the FDA’s 510(k) registry, reflecting their authorised status for intracranial monitoring and neurosurgical applications. The manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

Company details

FDA FEI number
3000204775
Address
ROAD 402 NORTH, KM 1.2, ANASCO, PR, 00610

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 5 recalls initiated by INTEGRA NEUROSCIENCES, the earliest on 2005-01-21 and the most recent on 2009-03-16. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2009

    • 16 Mar 2009 Z-2053-2009 Unclassified (pre-2012) Terminated Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip. Distribution: Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia. Submission number: K904883

  • 2008

    • 28 Jan 2008 Z-1191-2008 Unclassified (pre-2012) Terminated Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg. Distribution: USA Distribution: CA, GA, NM, TX, NE, WA, and NY. Submission number: K071505

  • 2005

    • 8 Sep 2005 Z-0339-06 Unclassified (pre-2012) Terminated Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of 2 mmHg maximum ICP drift within the first 24 hours of monitoring. Distribution: Nationwide Submission number: K050720
    • 21 Jan 2005 Z-0622-05 Unclassified (pre-2012) Terminated LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever. Distribution: LA, CA, CO, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, NE, NY, OH, OR, PA, SD, TN, TX, VA Submission number: K002765
    • 21 Jan 2005 Z-0623-05 Unclassified (pre-2012) Terminated LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever. Distribution: LA, CA, CO, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MT, NC, NE, NY, OH, OR, PA, SD, TN, TX, VA

Frequently asked questions

How many devices does INTEGRA NEUROSCIENCES have in the registry?

The registry currently lists 9 devices for INTEGRA NEUROSCIENCES. Devices recorded under merged duplicate company entries are counted once.

Which registries list INTEGRA NEUROSCIENCES's devices?

Among its 9 most recently registered devices, INTEGRA NEUROSCIENCES has devices listed in FDA 510(k) (9 devices).

What risk classes do INTEGRA NEUROSCIENCES's devices fall under?

Among its 9 most recently registered devices, the classes recorded for INTEGRA NEUROSCIENCES's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for INTEGRA NEUROSCIENCES?

FDA recall records list 5 recalls initiated by INTEGRA NEUROSCIENCES, the most recent initiated on 16 Mar 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from INTEGRA NEUROSCIENCES in the registry?

The most recently registered devices listed for INTEGRA NEUROSCIENCES include AURAGEN CORTICAL SURFACE ELECTRODES, CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1, LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1, CC1.SB LUICOX IMC INTRODUCER KITS-IM, IM2, IM3, II1 LICOXIMC TEMPE and CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.