Cleared Traditional

K002765 - LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE

K002765 is an FDA 510(k) clearance for LICOX CMP MONITOR-AC3.1, manufactured by Integra Neurosciences. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K002765 · Integra Neurosciences · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
80d
Days
Class 2
Risk

K002765 is an FDA 510(k) clearance for the LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INT.... Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Neurosciences (San Diego, US). The FDA issued a Cleared decision on November 24, 2000 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra Neurosciences devices

FDA 510(k) Submission Details - K002765

510(k) Number K002765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date November 24, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 51
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