FDA 510(k)

DANNIK Disposable Monopolar Laparoscopic Instrument

Número K: K193019 · 2020-03-04

RequerenteDannik

Data da decisão2020-03-04

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DANNIK Disposable Monopolar Laparoscopic Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2020-03-04 under 510(k) number K193019. 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 DANNIK Disposable Monopolar Laparoscopic Instrument?

DANNIK Disposable Monopolar Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2020-03-04. The listed applicant is Dannik. The 510(k) number is K193019.

When did DANNIK Disposable Monopolar Laparoscopic Instrument receive FDA 510(k) clearance?

DANNIK Disposable Monopolar Laparoscopic Instrument received FDA 510(k) clearance on 2020-03-04, under 510(k) number K193019.

Who is the listed applicant for DANNIK Disposable Monopolar Laparoscopic Instrument?

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

What is the FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument?

The FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument is GEI.

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Outros registros que listam Dannik como candidato(a)

K201063DANNIK Disposable Monopolar Laparoscopic Instrument K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)K192711Dannik Titanium Ligation Clip K192643Dannik Laparoscopic Suction Irrigation System

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Fonte oficial

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