Cleared Traditional

K170599 - SureFlo EVD Catheter

K170599 is an FDA 510(k) clearance for SureFlo EVD Catheter, manufactured by Arkis Biosciences, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K170599 · Arkis Biosciences, Inc. · Neurology device
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Aug 2017
Decision
183d
Days
Class 2
Risk

K170599 is an FDA 510(k) clearance for the SureFlo EVD Catheter. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Arkis Biosciences, Inc. (Knoxville, US). The FDA issued a Cleared decision on August 31, 2017 after a review of 183 days - an extended review 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: 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 Arkis Biosciences, Inc. devices

FDA 510(k) Submission Details - K170599

510(k) Number K170599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date August 31, 2017
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
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 181
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K170599.
EKOS ultrasound EVD Device, EVD Control Unit
K172035 · Btg International, Inc. · Mar 2018
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172537 · Codman & Shurtleff, Inc. · Oct 2017
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
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
K161992 · Integra LifeSciences Corporation · Sep 2016