FDA 510(k)

Endomat Select

Número K: K180735 · 2018-10-31

Data da decisão2018-10-31

Código do produtoHIG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Karl Storz SE & CO. KG como candidato(a)

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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.

Fonte oficial

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