FDA 510(k)

PeriView FLEX

N.º K: K171232 · 2017-09-21

SolicitanteOlympus Surgical Technologies America

Fecha de decisión2017-09-21

Código de productoKTI

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

PeriView FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K171232. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PeriView FLEX?

PeriView FLEX is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K171232.

When did PeriView FLEX receive FDA 510(k) clearance?

PeriView FLEX received FDA 510(k) clearance on 2017-09-21, under 510(k) number K171232.

Who is the listed applicant for PeriView FLEX?

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

What is the FDA product code for PeriView FLEX?

The FDA product code for PeriView FLEX is KTI.

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

Otros registros que enlistan a Olympus Surgical Technologies America como solicitante

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: KTI)

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

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.