FDA 510(k), K142432, StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
FDA 510(k), K142432, StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
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$149.00 USD
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510(K) Number: K142432
Device Name: StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
Manufacturer: BIONESS, INC.
Device Classification Name: stimulator, peripheral nerve, implanted (pain relief)
Regulation Number: 882.5870
Classification Product Code: GZF
Date Received: 08/29/2014
Decision Date: 02/20/2015
Regulation Medical Specialty: Neurology
Device Name: StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
Manufacturer: BIONESS, INC.
Device Classification Name: stimulator, peripheral nerve, implanted (pain relief)
Regulation Number: 882.5870
Classification Product Code: GZF
Date Received: 08/29/2014
Decision Date: 02/20/2015
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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