DURAFIBER Ag
K-Number: K161289 · 2016-08-03
ApplicantSmith & Nephew Medical Limited
Decision Date2016-08-03
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
DURAFIBER Ag is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2016-08-03 under approval number K161289. 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 DURAFIBER Ag?
DURAFIBER Ag is a medical device that received FDA 510(k) clearance on 2016-08-03. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K161289.
When was DURAFIBER Ag approved by the FDA?
DURAFIBER Ag received FDA 510(k) clearance on 2016-08-03, under approval number K161289.
What company makes DURAFIBER Ag?
DURAFIBER Ag is manufactured by Smith & Nephew Medical Limited.
What is the FDA product code for DURAFIBER Ag?
The FDA product code for DURAFIBER 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.