Cleared Traditional

K931989 - VENTRI-CATH

K931989 is an FDA 510(k) clearance for VENTRI-CATH, manufactured by Gesco Intl., Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K931989

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
Combination Product No
PCCP Authorized No
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.

JXG Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K931989.
CORDIS GRAVITY COMPENSATING ACCESSORY
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CORDIS POLYPROPYLENE BURR HOLE RESERVOIR
K925810 · Cordis Corp. · Mar 1994
CAMINO VENTRICULAR ACCESS DEVICE
K930222 · Camino Laboratories, Inc. · Apr 1993
PS MEDICAL CSF-ACCESS DEVICE
K913412 · Pudenz-Schulte Medical Research Corp. · Mar 1993
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS
K924600 · Cordis Corp. · Dec 1992