Cleared Traditional

K170368 - Sterile NS System

K170368 is the FDA 510(k) clearance for Sterile NS System by Jeil Medical Corporation. It is a Class 2 Neurology device (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

Submission Details

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.

Device Classification

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 27
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
PEEK Customized Cranial Implant
K153248 · Stryker · Mar 2016
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076 · Stryker · Aug 2015