FDA 510(k)

Monopolar Single Use Laparoscopic Instrument

Número K: K171523 · 2017-08-22

RequerenteGetsch+Hiller Medizintechnik GmbH

Data da decisão2017-08-22

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Monopolar Single Use Laparoscopic Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Getsch+Hiller Medizintechnik GmbH. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K171523. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Monopolar Single Use Laparoscopic Instrument?

Monopolar Single Use Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Getsch+Hiller Medizintechnik GmbH. The 510(k) number is K171523.

When did Monopolar Single Use Laparoscopic Instrument receive FDA 510(k) clearance?

Monopolar Single Use Laparoscopic Instrument received FDA 510(k) clearance on 2017-08-22, under 510(k) number K171523.

Who is the listed applicant for Monopolar Single Use Laparoscopic Instrument?

The FDA 510(k) record lists Getsch+Hiller Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monopolar Single Use Laparoscopic Instrument?

The FDA product code for Monopolar Single Use Laparoscopic Instrument is GEI.

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