FDA 510(k)

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

Número K: K200053 · 2020-04-21

RequerenteDannik

Data da decisão2020-04-21

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K200053. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Dannik. The 510(k) number is K200053.

When did DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) receive FDA 510(k) clearance?

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) received FDA 510(k) clearance on 2020-04-21, under 510(k) number K200053.

Who is the listed applicant for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

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 Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

The FDA product code for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is GCJ.

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Fonte oficial

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