FDA 510(k)

Dispositivo de Resseção Polygonal

Número K: K182675 · 2019-01-04

Data da decisão2019-01-04

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Polygon Resection Device is the device name listed in this FDA 510(k) record. The listed applicant is Polygon Medical, Inc.. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K182675. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Polygon Resection Device?

Polygon Resection Device is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Polygon Medical, Inc.. The 510(k) number is K182675.

When did Polygon Resection Device receive FDA 510(k) clearance?

Polygon Resection Device received FDA 510(k) clearance on 2019-01-04, under 510(k) number K182675.

Who is the listed applicant for Polygon Resection Device?

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

What is the FDA product code for Polygon Resection Device?

The FDA product code for Polygon Resection Device is HIH.

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