FDA 510(k)

Flexible Intubation Video Endoscope – Sterile (FIVE-S)

N.º K: K212656 · 2021-12-29

Fecha de decisión2021-12-29

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2021-12-29 under 510(k) number K212656. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) is a medical device that received FDA 510(k) clearance on 2021-12-29. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K212656.

When did Flexible Intubation Video Endoscope – Sterile (FIVE-S) receive FDA 510(k) clearance?

Flexible Intubation Video Endoscope – Sterile (FIVE-S) received FDA 510(k) clearance on 2021-12-29, under 510(k) number K212656.

Who is the listed applicant for Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S)?

The FDA product code for Flexible Intubation Video Endoscope – Sterile (FIVE-S) is EOQ.

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Otros registros que enlistan a Karl Storz Endoscopy America como solicitante

K212458Flexible Video-Uretero-Renoscope SSU System K212695KARL STORZ ICG Imaging System K201001Modulith SLX-F2 K201526TIPCAM1 Rubina Video Endoscope System

Dispositivos relacionados (Código: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Fuente oficial

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