Cleared Traditional

K021653 - CODMAN BACTISEAL EVD CATHETER SET

K021653 is the FDA 510(k) clearance for CODMAN BACTISEAL EVD CATHETER SET by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K021653 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
70d
Days
Class 2
Risk

K021653 is an FDA 510(k) clearance for the CODMAN BACTISEAL EVD CATHETER SET. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K021653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date July 29, 2002
Days to Decision 70 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
78d faster than avg
Panel avg: 148d · This submission: 70d
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 117
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K021653.
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc. · Jun 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · Aesculap, Inc. · Mar 2003
CODMAN HAKIM SHUNT SYSTEMS
K020667 · Codman & Shurtleff, Inc. · Mar 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · Codman & Shurtleff, Inc. · Dec 2000