FDA 510(k)

RENASYS Y-Connector; RENASYS TOUCH

N.º K: K181204 · 2019-01-10

SolicitanteSmith & Nephew Medical Limited

Fecha de decisión2019-01-10

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

RENASYS Y-Connector; RENASYS TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K181204. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the RENASYS Y-Connector; RENASYS TOUCH?

RENASYS Y-Connector; RENASYS TOUCH is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181204.

When did RENASYS Y-Connector; RENASYS TOUCH receive FDA 510(k) clearance?

RENASYS Y-Connector; RENASYS TOUCH received FDA 510(k) clearance on 2019-01-10, under 510(k) number K181204.

Who is the listed applicant for RENASYS Y-Connector; RENASYS TOUCH?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS Y-Connector; RENASYS TOUCH?

The FDA product code for RENASYS Y-Connector; RENASYS TOUCH is OMP.

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 Smith & Nephew Medical Limited como solicitante

K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove K223526ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing K220964VERSAJET Hydrosurgery System (III)K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large K223041Renasys Edge (66803126)K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

Ver todos los 21 dispositivos →

Dispositivos relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, 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.