SilverStream Gel
K-Number: K200767 · 2020-10-08
Device Summary
SilverStream Gel is a medical device manufactured by Enzysurge , Ltd.. It received FDA 510(k) clearance on 2020-10-08 under approval 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.
Frequently Asked Questions
What is the SilverStream Gel?
SilverStream Gel is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by Enzysurge , Ltd.. The 510(k) number is K200767.
When was SilverStream Gel approved by the FDA?
SilverStream Gel received FDA 510(k) clearance on 2020-10-08, under approval number K200767.
What company makes SilverStream Gel?
SilverStream Gel is manufactured by Enzysurge , Ltd..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.