Cleared Traditional

K943987 - OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE

K943987 is an FDA 510(k) clearance for OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE..., manufactured by Innerspace Medical, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K943987 · Innerspace Medical, Inc. · Neurology device
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Dec 1994
Decision
113d
Days
Class 2
Risk

K943987 is an FDA 510(k) clearance for the OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Innerspace Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innerspace Medical, Inc. devices

FDA 510(k) Submission Details - K943987

510(k) Number K943987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date December 07, 1994
Days to Decision 113 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
35d faster than avg
Panel avg: 148d · This submission: 113d
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 72
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K943987.
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
K962928 · Camino Neurocare, Inc. · Dec 1996
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585 · Johnson & Johnson Professionals, Inc. · Oct 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221 · Camino Laboratories, Inc. · Apr 1993
MODEL 704
K912139 · Ivy Biomedical Systems, Inc. · Mar 1992