Cleared Traditional

K962097 - VENTRICULAR CATHETER SET

K962097 is the FDA 510(k) clearance for VENTRICULAR CATHETER SET by Cook, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K962097 · Cook, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
92d
Days
Class 2
Risk

K962097 is an FDA 510(k) clearance for the VENTRICULAR CATHETER SET. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 29, 1996 after a review of 92 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 Cook, Inc. devices

Submission Details

510(k) Number K962097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1996
Decision Date August 29, 1996
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K962097.
CORDIS SHARP-ENDED STYLET
K955265 · Cordis Corp. · Dec 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp. · Oct 1996
RADIONICS SIPHON LIMITING DEVICE (SLD)
K962990 · Radionics, Inc. · Oct 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · Cordis Corp. · Mar 1996
CONTOUR FLEX VALVES (REGULAR & SMALL)
K954285 · Radionics, Inc. · Jan 1996
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · Johnson & Johnson Professionals, Inc. · Oct 1995