Cleared Traditional

K200848 - Stimulator

K200848 is the FDA 510(k) clearance for Stimulator by Micron Medical Corporation. It is a Class 2 Neurology device (product code GZF) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K200848 · Micron Medical Corporation · Neurology device
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Aug 2020
Decision
136d
Days
Class 2
Risk

K200848 is an FDA 510(k) clearance for the Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Micron Medical Corporation (Boca Raton, US). The FDA issued a Cleared decision on August 14, 2020 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5870 - 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 Micron Medical Corporation devices

Submission Details

510(k) Number K200848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2020
Decision Date August 14, 2020
Days to Decision 136 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
12d faster than avg
Panel avg: 148d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5870
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 - GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)

All 19
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K200848.
Neuspera Nuity System
K221303 · Neuspera Medical, Inc. · Apr 2023
StimRouter Neuromodulation System
K211965 · Bioness, Inc. · Feb 2022
Neuspera Neurostimulation System (NNS)
K202781 · Neuspera Medical, Inc. · Aug 2021
StimRouter Neuromodulation System
K200482 · Bioness, Inc. · Mar 2020
StimRouter Neuromodulation System
K190047 · Bioness, Inc. · Oct 2019
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
K191435 · Nalu Medical, Inc. · Sep 2019