Cleared Special

K110118 - STIMTRODE SINGLE USE NERVE STIMULATOR

K110118 is an FDA 510(k) clearance for STIMTRODE SINGLE USE NERVE STIMULATOR, manufactured by Xavant Technology (Pty), Ltd.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Special 510(k) pathway after a 30-day FDA review.

K110118 · Xavant Technology (Pty), Ltd. · Anesthesiology device
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Feb 2011
Decision
30d
Days
Class 2
Risk

K110118 is an FDA 510(k) clearance for the STIMTRODE SINGLE USE NERVE STIMULATOR. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Xavant Technology (Pty), Ltd. (Pretoria, Gauteng, ZA). The FDA issued a Cleared decision on February 17, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Xavant Technology (Pty), Ltd. devices

FDA 510(k) Submission Details - K110118

510(k) Number K110118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date February 17, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

BXN Device Classification - Class 2, Special Controls

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BXN Stimulator, Nerve, Battery-powered

All 32
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K110118.
STIMPOD ST2-3010 NERVE STIMULATOR
K140853 · Xavant Technology (Pty), Ltd. · Nov 2014
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K121743 · Sunmed, LLC · Mar 2013
MYOGUIDE SYSTEM MODEL 8008
K111985 · Intronix Technologies Corp. · Dec 2011
STIMPOD NMS450 NERVE STIMULATOR
K102084 · Xavant Technology (Pty), Ltd. · Dec 2010
STIMPOD MODEL NMS-400 NERVE STIMULATOR
K093591 · Xavant Technology (Pty), Ltd. · Dec 2009
ASCEND
K091155 · Neurometrix, Inc. · Sep 2009