FDA 510(k)

Disposable Monopolar Laparoscopic Shafts and Reusable Handles

Número K: K210569 · 2021-08-16

Data da decisão2021-08-16

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Monopolar Laparoscopic Shafts and Reusable Handles is the device name listed in this FDA 510(k) record. The listed applicant is Dannik, LLC. It received FDA 510(k) clearance on 2021-08-16 under 510(k) number K210569. 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 Disposable Monopolar Laparoscopic Shafts and Reusable Handles?

Disposable Monopolar Laparoscopic Shafts and Reusable Handles is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Dannik, LLC. The 510(k) number is K210569.

When did Disposable Monopolar Laparoscopic Shafts and Reusable Handles receive FDA 510(k) clearance?

Disposable Monopolar Laparoscopic Shafts and Reusable Handles received FDA 510(k) clearance on 2021-08-16, under 510(k) number K210569.

Who is the listed applicant for Disposable Monopolar Laparoscopic Shafts and Reusable Handles?

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

What is the FDA product code for Disposable Monopolar Laparoscopic Shafts and Reusable Handles?

The FDA product code for Disposable Monopolar Laparoscopic Shafts and Reusable Handles is GEI.

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Outros registros que listam Dannik, LLC como candidato(a)

K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System K211019Disposable Monopolar Laparoscopic Tips and Reusable Handles

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Fonte oficial

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