BXN · Class II · 21 CFR 868.2775

FDA Product Code BXN: Stimulator, Nerve, Battery-powered

Leading manufacturers include Xavant Technology (Pty), Ltd., Biometer Intl. A/S and Stockert GmbH.

63
Total
63
Cleared
124d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Stimulator, Nerve, Battery-powered Devices (Product Code BXN)

63 devices
1–24 of 63
Cleared Oct 16, 2022
STIMPOD NMS450 Nerve Stimulator
K213049
Xavant Technology (Pty), Ltd.
Anesthesiology · 389d
Cleared Jan 06, 2017
MultiStim ECO
K162086
PAJUNK GmbH Medizintechnologie
Anesthesiology · 163d
Cleared May 13, 2016
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K153045
Easy Med Instrument Co., Ltd.
Anesthesiology · 207d
Cleared Mar 24, 2015
MiniStim MS-IVB Peripheral Nerve Stimulator
K143095
Halyard Health, Inc.
Anesthesiology · 147d
Cleared Nov 06, 2014
STIMPOD ST2-3010 NERVE STIMULATOR
K140853
Xavant Technology (Pty), Ltd.
Anesthesiology · 217d
Cleared Mar 28, 2013
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K121743
Sunmed, LLC
Anesthesiology · 288d
Cleared Dec 30, 2011
MYOGUIDE SYSTEM MODEL 8008
K111985
Intronix Technologies Corp.
Anesthesiology · 171d
Cleared Feb 17, 2011
STIMTRODE SINGLE USE NERVE STIMULATOR
K110118
Xavant Technology (Pty), Ltd.
Anesthesiology · 30d
Cleared Dec 16, 2010
STIMPOD NMS450 NERVE STIMULATOR
K102084
Xavant Technology (Pty), Ltd.
Anesthesiology · 143d
Cleared Dec 03, 2009
STIMPOD MODEL NMS-400 NERVE STIMULATOR
K093591
Xavant Technology (Pty), Ltd.
Anesthesiology · 14d
Cleared Sep 03, 2009
ASCEND
K091155
Neurometrix, Inc.
Anesthesiology · 135d
Cleared Nov 15, 2007
XPOD/XMAP NERVE STIMULATOR
K072092
Xavant Technology (Pty), Ltd.
Anesthesiology · 108d
Cleared Mar 22, 2007
MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
K070134
Stockert GmbH
Anesthesiology · 65d
Cleared Feb 08, 2007
CLAVIS
K062478
Medtronic A/S
Anesthesiology · 168d
Cleared Nov 21, 2006
STIMUPLEX PEN
K061983
Stockert GmbH
Anesthesiology · 131d
Cleared Oct 17, 2006
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K061172
PAJUNK GmbH Medizintechnologie
Anesthesiology · 173d
Cleared Nov 17, 2005
STIMUPLEX HNS-12, MODEL 4892098
K052313
Stockert GmbH
Anesthesiology · 84d
Cleared Mar 21, 2003
STIMUPLEX-DIG-RC NERVE STIMULATOR
K021033
B.Braun Medical, Inc.
Anesthesiology · 357d
Cleared Nov 29, 2001
MULTISTIM
K011308
Pajunk GmbH
Anesthesiology · 213d
Cleared Sep 28, 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323
Te ME NA S.A.R.L.
Anesthesiology · 969d
Cleared Jun 06, 2001
STIMUPLEX HNS-11
K003983
Stockert GmbH
Anesthesiology · 162d
Cleared Jan 19, 1996
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
K954525
Sherwood Medical Co.
Anesthesiology · 112d
Cleared Apr 09, 1993
VITALMAX 840 SERIES
K914164
Pace Tech Medical Monitors, Inc.
Anesthesiology · 570d
Cleared Oct 07, 1991
MS-III MINISTIM
K913184
Life-Tech Intl., Inc.
Anesthesiology · 81d

About Product Code BXN - Regulatory Context

510(k) Submission Activity

63 total 510(k) submissions under product code BXN since 1976, with 63 receiving FDA clearance (average review time: 124 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.