FDA 510(k)

Freedom Peripheral Nerve Stimulator (PNS) System

N.º K: K233162 · 2024-06-20

SolicitanteCuronix

Fecha de decisión2024-06-20

Código de productoGZF

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Freedom Peripheral Nerve Stimulator (PNS) System is the device name listed in this FDA 510(k) record. The listed applicant is Curonix. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K233162. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Freedom Peripheral Nerve Stimulator (PNS) System?

Freedom Peripheral Nerve Stimulator (PNS) System is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Curonix. The 510(k) number is K233162.

When did Freedom Peripheral Nerve Stimulator (PNS) System receive FDA 510(k) clearance?

Freedom Peripheral Nerve Stimulator (PNS) System received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233162.

Who is the listed applicant for Freedom Peripheral Nerve Stimulator (PNS) System?

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

What is the FDA product code for Freedom Peripheral Nerve Stimulator (PNS) System?

The FDA product code for Freedom Peripheral Nerve Stimulator (PNS) System is GZF.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: GZF)

K253877StimTrial Neuromodulation SystemBioventus, LLC K243782StimTrial Neuromodulation SystemBioventus, LLC K243678TalisMann Neuromodulation SystemBioventus, LLC K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221303Neuspera Nuity SystemNeuspera Medical, Inc.K211965StimRouter Neuromodulation SystemBioness, 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.