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BXN — Stimulator, Nerve, Battery-Powered Class II

FDA Device Classification

Classification Details

Product Code
BXN
Device Class
Class II
Regulation Number
868.2775
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213049xavant technology (pty)STIMPOD NMS450 Nerve StimulatorOctober 16, 2022
K162086pajunk gmbh medizintechnologieMultiStim ECOJanuary 6, 2017
K153045easy med instrument coSunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorMay 13, 2016
K143095halyard healthMiniStim MS-IVB Peripheral Nerve StimulatorMarch 24, 2015
K140853xavant technology (pty)STIMPOD ST2-3010 NERVE STIMULATORNovember 6, 2014
K121743sunmedEASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINMarch 28, 2013
K111985intronix technologiesMYOGUIDE SYSTEM MODEL 8008December 30, 2011
K110118xavant technology (pty)STIMTRODE SINGLE USE NERVE STIMULATORFebruary 17, 2011
K102084xavant technology (pty)STIMPOD NMS450 NERVE STIMULATORDecember 16, 2010
K093591xavant technology (pty)STIMPOD MODEL NMS-400 NERVE STIMULATORDecember 3, 2009
K091155neurometrixASCENDSeptember 3, 2009
K072092xavant technology (pty)XPOD/XMAP NERVE STIMULATORNovember 15, 2007
K070134stockertMODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098March 22, 2007
K062478medtronicCLAVISFebruary 8, 2007
K061983stockertSTIMUPLEX PENNovember 21, 2006
K061172pajunk gmbh medizintechnologiePAJUNK MULTISTIM SENSOR NERVE STIMULATORSOctober 17, 2006
K052313stockertSTIMUPLEX HNS-12, MODEL 4892098November 17, 2005
K021033b.braun medicalSTIMUPLEX-DIG-RC NERVE STIMULATORMarch 21, 2003
K011308pajunkMULTISTIMNovember 29, 2001
K990323te me na s.a.r.lTE ME NA POLYSTIM NERVE STIMILATORSeptember 28, 2001