Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Tisuthes e-PTFE Surgical Patch

N.º K: K201153 · 2023-06-13

SolicitanteShanghai Suokang Medical Implants Co., Ltd.
Fecha de decisión2023-06-13
Código de productoOWR
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Tisuthes e-PTFE Surgical Patch is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K201153. The device is classified under product code OWR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tisuthes e-PTFE Surgical Patch?

Tisuthes e-PTFE Surgical Patch is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Shanghai Suokang Medical Implants Co., Ltd.. The 510(k) number is K201153.

When did Tisuthes e-PTFE Surgical Patch receive FDA 510(k) clearance?

Tisuthes e-PTFE Surgical Patch received FDA 510(k) clearance on 2023-06-13, under 510(k) number K201153.

Who is the listed applicant for Tisuthes e-PTFE Surgical Patch?

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

What is the FDA product code for Tisuthes e-PTFE Surgical Patch?

The FDA product code for Tisuthes e-PTFE Surgical Patch is OWR.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑