Cleared Traditional

K011702 - VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX

K011702 is an FDA 510(k) clearance for VERTIS PNT CONTROL UNIT, manufactured by Vertis Neuroscience, Inc.. The device is a Class 2 Neurology device with product code NHI cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K011702 · Vertis Neuroscience, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
203d
Days
Class 2
Risk

K011702 is an FDA 510(k) clearance for the VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX. Classified as Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (product code NHI), Class II - Special Controls.

Submitted by Vertis Neuroscience, Inc. (Seattle, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 203 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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.

FDA 510(k) Submission Details - K011702

510(k) Number K011702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2001
Decision Date December 21, 2001
Days to Decision 203 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
54d slower than avg
Panel avg: 149d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHI Device Classification - Class 2, Special Controls

Product Code NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,
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 - NHI Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief

All 12
Devices cleared under the same product code (NHI) and FDA review panel - the closest regulatory comparables to K011702.
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
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DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
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VERTIS PNT CONTROL UNIT, MODEL CU 100
K022241 · Vertis Neuroscience, Inc. · Sep 2002
K011702 · VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
Download PDF FDA Summary Vertis Neuroscience, …