FDA 510(k)

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

N.º K: K180981 · 2018-09-19

SolicitanteStimwave Technologies Incorporated

Fecha de decisión2018-09-19

Código de productoGZB

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit 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 2018-09-19 under 510(k) number K180981. 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 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K180981.

When did Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit receive FDA 510(k) clearance?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit received FDA 510(k) clearance on 2018-09-19, under 510(k) number K180981.

Who is the listed applicant for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

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 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

The FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is GZB.

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Otros registros que enlistan a Stimwave Technologies Incorporated como solicitante

K182720Freedom Spinal Cord Stimulator (SCS) System 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 K160600Sistema de Estimulador Espinal de Libertad

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

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