Cleared Traditional

K170368 - Sterile NS System

K170368 is an FDA 510(k) clearance for Sterile NS System, manufactured by Jeil Medical Corporation. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K170368 · Jeil Medical Corporation · Neurology device
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Sep 2017
Decision
217d
Days
Class 2
Risk

K170368 is an FDA 510(k) clearance for the Sterile NS System. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on September 11, 2017 after a review of 217 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - 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 Jeil Medical Corporation devices

FDA 510(k) Submission Details - K170368

510(k) Number K170368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2017
Decision Date September 11, 2017
Days to Decision 217 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
69d slower than avg
Panel avg: 148d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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 - GWO Plate, Cranioplasty, Preformed, Alterable

All 38
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K170368.
Optimus Neuro System
K183352 · Osteonic Co., Ltd. · Jan 2019
Universal Mesh - Sterile
K182425 · Stryker Leibinger GmbH & Co KG · Nov 2018
Stryker Universal Mesh
K170725 · Stryker · Nov 2017
Stryker Universal Mesh
K161821 · Stryker · Dec 2016
Biopor Porous Polyethylene Implants
K161446 · Ceremed , Inc. · Sep 2016
PEEK Customized Cranial Implant
K153248 · Stryker · Mar 2016