SilverSeal
K-Number: K171041 · 2017-08-22
ApplicantAlliqua Biomedical, Inc.
Decision Date2017-08-22
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
SilverSeal is a medical device manufactured by Alliqua Biomedical, Inc.. It received FDA 510(k) clearance on 2017-08-22 under approval number K171041. 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 SilverSeal?
SilverSeal is a medical device that received FDA 510(k) clearance on 2017-08-22. It is manufactured by Alliqua Biomedical, Inc.. The 510(k) number is K171041.
When was SilverSeal approved by the FDA?
SilverSeal received FDA 510(k) clearance on 2017-08-22, under approval number K171041.
What company makes SilverSeal?
SilverSeal is manufactured by Alliqua Biomedical, Inc..
What is the FDA product code for SilverSeal?
The FDA product code for SilverSeal 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.