FDA 510(k)

Aplicación de Biopsia Craneal y Colocación de Catéter Ventricular del Sistema Quirúrgico 7D

N.º K: K192945 · 2019-11-27

Fecha de decisión2019-11-27

Código de productoHAW

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K192945. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application?

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K192945.

When did 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application receive FDA 510(k) clearance?

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application received FDA 510(k) clearance on 2019-11-27, under 510(k) number K192945.

Who is the listed applicant for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application?

The FDA product code for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is HAW.

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Otros registros que enlistan a 7D Surgical, Inc. como solicitante

K210457Marco de Registro 7D, Conector de Pin Iliaco Flex 7D, Bloque de Guía de Pin 7D, Pin Steinmann 3.2 mm 7D, Chuck y Llave de Cresta Iliaca 7D K210555Sistema Quirúrgico 7D - Guía de Taladro K201966FlashLock 1 Quirúrgico 7D, Conector de Varilla Flexible Quirúrgico 7D - 5.5 mm - 150 mm, Flex Array Quirúrgico 7D K192140Sistema Quirúrgico 7D K183276Sistema Quirúrgico 7D K181041Aplicación Craneal del Sistema Quirúrgico 7D

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: HAW)

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Fuente oficial

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