FDA 510(k)

Sharpsite AC Rigid Endsocope

Número K: K173855 · 2018-04-20

Data da decisão2018-04-20

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sharpsite AC Rigid Endsocope is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K173855. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sharpsite AC Rigid Endsocope?

Sharpsite AC Rigid Endsocope is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K173855.

When did Sharpsite AC Rigid Endsocope receive FDA 510(k) clearance?

Sharpsite AC Rigid Endsocope received FDA 510(k) clearance on 2018-04-20, under 510(k) number K173855.

Who is the listed applicant for Sharpsite AC Rigid Endsocope?

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

What is the FDA product code for Sharpsite AC Rigid Endsocope?

The FDA product code for Sharpsite AC Rigid Endsocope is EOB.

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