FDA 510(k)

Sistema de Estimulador Espinal de Libertad

N.º K: K160600 · 2016-08-26

SolicitanteStimwave Technologies Incorporated

Fecha de decisión2016-08-26

Código de productoGZB

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Freedom Spinal Cord Stimulator System is the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160600. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Freedom Spinal Cord Stimulator System?

Freedom Spinal Cord Stimulator System is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K160600.

When did Freedom Spinal Cord Stimulator System receive FDA 510(k) clearance?

Freedom Spinal Cord Stimulator System received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160600.

Who is the listed applicant for Freedom Spinal Cord Stimulator System?

The FDA 510(k) record lists Stimwave Technologies Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freedom Spinal Cord Stimulator System?

The FDA product code for Freedom Spinal Cord Stimulator System is GZB.

Ensayos clínicos relacionados

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Otros registros que enlistan a Stimwave Technologies Incorporated como solicitante

K182720Freedom Spinal Cord Stimulator (SCS) System K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

Dispositivos relacionados (Código: GZB)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation K202274Kit de Neuroestimulación Nalu (lnte:gmted 40 em: Single 8/Dual 8), Kit de Neuroestimulación Nalu (Ported, 2 em: Single 8/Dual8), Generador de Pulsos Implantable Nalu Dual 8 Ported con 40 ern Kil, Kits de PruebaJExtension Lead de 40 cm/ 60 cm/60 em, Kits de Paciente y kits de repuestos variosBoston Scientific Neuromodulation K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.