Cleared Traditional

K172537 - Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag

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

K172537 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K172537

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
94d faster than avg
Panel avg: 149d · This submission: 55d
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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K172537.
EKOS ultrasound EVD Device, EVD Control Unit
K172035 · Btg International, Inc. · Mar 2018
Smart External Drain (SED) System
K172759 · Aqueduct Critical Care, Inc. · Nov 2017
Alivio Ventricular Catheter and Flusher System (Alivio System)
K172006 · Alcyone Lifesciences, Inc. · Nov 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · Codman & Shurtleff, Inc. · Oct 2017
SureFlo EVD Catheter
K170599 · Arkis Biosciences, Inc. · Aug 2017
Smart External Drain (SED) System
K171586 · Aqueduct Critical Care, Inc. · Jun 2017
K172537 · Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
Download PDF FDA Summary Codman & Shurtleff, I…