FDA 510(k)

SilverStream Gel

Número K: K200767 · 2020-10-08

Data da decisão2020-10-08

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SilverStream Gel is the device name listed in this FDA 510(k) record. The listed applicant is Enzysurge , Ltd.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K200767. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SilverStream Gel?

SilverStream Gel is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Enzysurge , Ltd.. The 510(k) number is K200767.

When did SilverStream Gel receive FDA 510(k) clearance?

SilverStream Gel received FDA 510(k) clearance on 2020-10-08, under 510(k) number K200767.

Who is the listed applicant for SilverStream Gel?

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

What is the FDA product code for SilverStream Gel?

The FDA product code for SilverStream Gel is FRO. This falls under the Anesthesiology category.

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