FDA 510(k)

Disposable Monopolar Laparoscopic Shafts and Reusable Handles

N.º K: K210569 · 2021-08-16

Fecha de decisión2021-08-16

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Dannik, LLC como solicitante

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

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Fuente oficial

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