Cleared Traditional

K883881 - MODIFIED MODEL 2001 FIBER OPTICS CATHETER

K883881 is the FDA 510(k) clearance for MODIFIED MODEL 2001 FIBER OPTICS CATHETER by Metatech Corp.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883881 · Metatech Corp. · Neurology device
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Oct 1988
Decision
90d
Days
Class 2
Risk

K883881 is an FDA 510(k) clearance for the MODIFIED MODEL 2001 FIBER OPTICS CATHETER. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Metatech Corp. (Wheeling, US). The FDA issued a Cleared decision on October 27, 1988 after a review of 90 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 Metatech Corp. devices

Submission Details

510(k) Number K883881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1988
Decision Date October 27, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K883881.
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984