Cleared Traditional

CORDIS SHARP-ENDED STYLET (K955265) - FDA 510(k) Clearance

Also marketed or referenced as:
BLUNT-ENDED STYLET CYST PUNCTURE CATHETER

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955265 · Cordis Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
402d
Days
Class 2
Risk

K955265 is an FDA 510(k) clearance for the CORDIS SHARP-ENDED STYLET. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on December 20, 1996 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Cordis Corp. devices

Submission Details

510(k) Number K955265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1995
Decision Date December 20, 1996
Days to Decision 402 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
254d slower than avg
Panel avg: 148d · This submission: 402d
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 94
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K955265.
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · Johnson & Johnson Professionals, Inc. · Jul 1998
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · Johnson & Johnson Professionals, Inc. · Dec 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc. · Jun 1997
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · Cordis Corp. · Oct 1996
VENTRICULAR CATHETER SET
K962097 · Cook, Inc. · Aug 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · Cordis Corp. · Mar 1996