FDA 510(k)

Endomat Select

N.º K: K180735 · 2018-10-31

Fecha de decisión2018-10-31

Código de productoHIG

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Endomat Select is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K180735. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Endomat Select?

Endomat Select is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K180735.

When did Endomat Select receive FDA 510(k) clearance?

Endomat Select received FDA 510(k) clearance on 2018-10-31, under 510(k) number K180735.

Who is the listed applicant for Endomat Select?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endomat Select?

The FDA product code for Endomat Select is HIG.

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Otros registros que enlistan a Karl Storz SE & CO. KG como solicitante

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)K254303KARL STORZ SUPRALOOP K261102UNIDRIVE Select System K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)K260884UNIDRIVE Select System K254103HOPKINS Telescopes for Arthroscopy

Ver todos los 33 dispositivos →

Dispositivos relacionados (Código: HIG)

K261706Endomat Select (UP220)KARL STORZ SE & CO. KG K251273Asurys Fluid Management SystemBoston Scientific Corporation K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLC K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG K180825Fluent Fluid Management SystemHologic, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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