FDA 510(k)

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

N.º K: K160969 · 2016-12-12

Fecha de decisión2016-12-12

Código de productoGDW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Shinemed, LLC. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K160969. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Shinemed, LLC. The 510(k) number is K160969.

When did ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler receive FDA 510(k) clearance?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler received FDA 510(k) clearance on 2016-12-12, under 510(k) number K160969.

Who is the listed applicant for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

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

What is the FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

The FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is GDW.

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: GDW)

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.