510(k) Report

FDA applicant

Integra Neurosciences

San Diego, CA9 decisions2000–20088 recalls

FDA records 9 decisions for Integra Neurosciences (San Diego, CA) from 2000 to 2008: 9 510(k) clearances. Most are in product codes GWM (Device, Monitoring, Intracranial Pressure) and LFL (Instrument, Ultrasonic Surgical). Its devices cite 13 predicates, 2 of them its own earlier devices. 8 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Integra Neurosciences, Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Integra Neurosciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2019

2010: 12014: 12019: 2, 2 Class I
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Integra Neurosciences by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Integra Neurosciences’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GWMDevice, Monitoring, Intracranial Pressure5decisions
  • LFLInstrument, Ultrasonic Surgical2decisions
  • GYCElectrode, Cortical1decision
  • JXGShunt, Central Nervous System And Components1decision

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002765Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1…Integra Neurosciences · 20009cite it
  • K021989Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 20025cite it
  • K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 20023cite it
  • K022553Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4LIntegra Neurosciences · 20021cites it
  • K020558Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 20021cites it
  • K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 20041cites it

What has FDA decided for it lately?

  • K082250Auragen Cortical Surface ElectrodesIntegra Neurosciences · 2008
  • K050720Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/System, Models NS-P, NS-100Integra Neurosciences · 20051 recall
  • K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
  • K031086Camino Single Parameter Monitor, Model SPM-1Integra Neurosciences · 2003
  • K021989Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 20022 recalls
  • K022554Monitorr Icp External CSF Drainage and Monitoring SystemIntegra Neurosciences · 20022 Class I recalls
  • K022553Camino Intracranial Pressure Monitoring Catheter with Licox Imc Bolt Fitting, Model 110-4LIntegra Neurosciences · 2002
  • K020558Licox CC1.G2 Brain Oxygen Catheter-MicroprobeIntegra Neurosciences · 2002

All 8 as Integra Neurosciences →The one decision as Integra Neurosciences, Ltd. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K022554MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage…Apr 8, 2019Class I
  • K022554MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102…Apr 8, 2019Class I
  • K002765Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen…Nov 7, 2014Class II
  • K002765LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft…Dec 17, 2010
  • K021989Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical…Nov 28, 2005
  • K021989Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215…Sep 13, 2005

Other applicant names beginning “Integra”

FDA records each applicant name separately; these may or may not be the same firm.

Integra LifeSciences Corporation 101Integra Neurocare, LLC 12Integra Radionics, Inc. 10Integra Lifesciences Production Corporation 9Integra Neurosciences Implants S.A. 6Integra Life Sciences 3Integra Medical 2Integra Lifescience Corportation 2Integra Lifesciences Corporation (Owner of Tei… 1Integra Microfrance 1Integra Biotechnical, LLC 1Integra Burlington Ma, Inc. 1