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FDA 510(k)

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base

N.º K: K172644 · 2017-11-03

SolicitanteStimwave Technologies Incorporated
Fecha de decisión2017-11-03
Código de productoGZB
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base 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 2017-11-03 under 510(k) number K172644. 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 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base?

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K172644.

When did Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base receive FDA 510(k) clearance?

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base received FDA 510(k) clearance on 2017-11-03, under 510(k) number K172644.

Who is the listed applicant for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base?

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 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base?

The FDA product code for Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is GZB.

Ensayos clínicos relacionados

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Otros registros que enlistan a Stimwave Technologies Incorporated como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K182720Freedom Spinal Cord Stimulator (SCS) SystemK180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitK170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitK162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitK160600Sistema de Estimulador Espinal de Libertad

Dispositivos relacionados (Código: GZB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK221376Nalu Neurostimulation SystemBoston Scientific NeuromodulationK203547Nalu Neurostimulation SystemBoston Scientific NeuromodulationK202274Kit 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 NeuromodulationK201618Nalu Neurostimulation SCS systemBoston Scientific NeuromodulationK191466SandShark 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.

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