Exufiber Ag+
K-Number: K160379 · 2016-08-25
ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-08-25
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Exufiber Ag+ is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-08-25 under approval number K160379. 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 Exufiber Ag+?
Exufiber Ag+ is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K160379.
When was Exufiber Ag+ approved by the FDA?
Exufiber Ag+ received FDA 510(k) clearance on 2016-08-25, under approval number K160379.
What company makes Exufiber Ag+?
Exufiber Ag+ is manufactured by Molnlycke Health Care Us, LLC.
What is the FDA product code for Exufiber Ag+?
The FDA product code for Exufiber Ag+ 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.