Cleared Traditional

K172537 - Codman EDS 3 CSF External Drainage System

K172537 is the FDA 510(k) clearance for Codman EDS 3 CSF External Drainage System by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K172537 · Codman & Shurtleff, Inc. · Neurology device
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Oct 2017
Decision
55d
Days
Class 2
Risk

K172537 is an FDA 510(k) clearance for the Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage.... 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 October 16, 2017 after a review of 55 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 K172537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2017
Decision Date October 16, 2017
Days to Decision 55 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
93d faster than avg
Panel avg: 148d · This submission: 55d
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 K172537.
IRRAflow CNS System
K171880 · Irras, Inc. · Jul 2018
Smart External Drain (SED) System
K181301 · Aqueduct Critical Care, Inc. · Jun 2018
EKOS ultrasound EVD Device, EVD Control Unit
K172035 · Btg International, Inc. · Mar 2018
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · Codman & Shurtleff, Inc. · Oct 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
K161853 · Aesculap, Inc. · Feb 2017
Codman EDS3 CSF External Drainage System
K162437 · Codman & Shurtleff, Inc. · Oct 2016