FDA 510(k)

Pelican Sling Retractor

Número K: K153542 · 2016-09-07

Data da decisão2016-09-07

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pelican Sling Retractor is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Surgical, Inc.. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K153542. 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 Pelican Sling Retractor?

Pelican Sling Retractor is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Beacon Surgical, Inc.. The 510(k) number is K153542.

When did Pelican Sling Retractor receive FDA 510(k) clearance?

Pelican Sling Retractor received FDA 510(k) clearance on 2016-09-07, under 510(k) number K153542.

Who is the listed applicant for Pelican Sling Retractor?

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

What is the FDA product code for Pelican Sling Retractor?

The FDA product code for Pelican Sling Retractor is GCJ.

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