FDA 510(k)

Endomat Select, IBS Shaver Software, License

N.º K: K201355 · 2020-07-22

Fecha de decisión2020-07-22

Código de productoHIG

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Endomat Select, IBS Shaver Software, License 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 2020-07-22 under 510(k) number K201355. 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, IBS Shaver Software, License?

Endomat Select, IBS Shaver Software, License is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K201355.

When did Endomat Select, IBS Shaver Software, License receive FDA 510(k) clearance?

Endomat Select, IBS Shaver Software, License received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201355.

Who is the listed applicant for Endomat Select, IBS Shaver Software, License?

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, IBS Shaver Software, License?

The FDA product code for Endomat Select, IBS Shaver Software, License 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 K180735Endomat SelectKarl Storz SE & CO. KG K180825Fluent Fluid Management SystemHologic, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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