Cleared Traditional

K931989 - VENTRI-CATH

K931989 is the FDA 510(k) clearance for VENTRI-CATH by Gesco Intl., Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K931989 · Gesco Intl., Inc. · Neurology device
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Jul 1993
Decision
90d
Days
Class 2
Risk

K931989 is an FDA 510(k) clearance for the VENTRI-CATH. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on July 21, 1993 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 882.5550 - 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 Gesco Intl., Inc. devices

Submission Details

510(k) Number K931989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date July 21, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
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 JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 99
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K931989.
CODMAN-MEDOS VALVE SHUNT SYSTEM
K944222 · Johnson & Johnson Professionals, Inc. · Jul 1995
CORDIS GRAVITY COMPENSATING ACCESSORY
K932429 · Cordis Corp. · Jul 1994
CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp. · Mar 1994
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600 · Cordis Corp. · Dec 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
K921936 · Cordis Corp. · Oct 1992
CORDIS STRAIGHT VENTRICULAR CATHETER
K914995 · Cordis Corp. · Mar 1992