FDA 510(k)

Well Lead All Silicone Foley Catheter with Temperature Sensor

N.º K: K202134 · 2021-04-08

Fecha de decisión2021-04-08

Código de productoEZL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Well Lead All Silicone Foley Catheter with Temperature Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-04-08 under 510(k) number K202134. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Well Lead All Silicone Foley Catheter with Temperature Sensor?

Well Lead All Silicone Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2021-04-08. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K202134.

When did Well Lead All Silicone Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

Well Lead All Silicone Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2021-04-08, under 510(k) number K202134.

Who is the listed applicant for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor?

The FDA product code for Well Lead All Silicone Foley Catheter with Temperature Sensor is EZL.

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 Well Lead Medical Co., Ltd. como solicitante

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact K220722PVC Hydrophilic Urethral Catheter K220036Wellead Ureteral Catheter K211543Wei Nasal Jet Tube K211814Wellead Endoscopic Seal K203119ClearPetra Suction-Evacuation Sheath

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: EZL)

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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.