FDA 510(k)

Disposable Enteral Feeding Syringe with Enfit Connector

N.º K: K193657 · 2020-09-12

SolicitanteShinva Ande Healthcare Apparatus Co., Ltd.

Fecha de decisión2020-09-12

Código de productoPNR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Enteral Feeding Syringe with Enfit Connector is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2020-09-12 under 510(k) number K193657. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Enteral Feeding Syringe with Enfit Connector?

Disposable Enteral Feeding Syringe with Enfit Connector is a medical device that received FDA 510(k) clearance on 2020-09-12. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K193657.

When did Disposable Enteral Feeding Syringe with Enfit Connector receive FDA 510(k) clearance?

Disposable Enteral Feeding Syringe with Enfit Connector received FDA 510(k) clearance on 2020-09-12, under 510(k) number K193657.

Who is the listed applicant for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector?

The FDA product code for Disposable Enteral Feeding Syringe with Enfit Connector is PNR.

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 Shinva Ande Healthcare Apparatus Co., Ltd. como solicitante

K201460Closed System Transfer Device K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization K211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles K202060Disposable IV catheter K162601Infusion Set for Single Use

Dispositivos relacionados (Código: PNR)

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.