FDA 510(k)

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

N.º K: K191387 · 2019-06-14

Fecha de decisión2019-06-14

Código de productoKNT

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is the device name listed in this FDA 510(k) record. The listed applicant is Envizion Medical , Ltd.. It received FDA 510(k) clearance on 2019-06-14 under 510(k) number K191387. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Envizion Medical , Ltd.. The 510(k) number is K191387.

When did ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube receive FDA 510(k) clearance?

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube received FDA 510(k) clearance on 2019-06-14, under 510(k) number K191387.

Who is the listed applicant for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

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

What is the FDA product code for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube?

The FDA product code for ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube is KNT.

Ensayos clínicos relacionados

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Otros registros que enlistan a Envizion Medical , Ltd. como solicitante

K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube

Dispositivos relacionados (Código: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

Fuente oficial

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