Microcyn Plus Wound Care Solution
K-Number: K161034 · 2016-08-19
ApplicantOculus Innovative Sciences
Decision Date2016-08-19
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Microcyn Plus Wound Care Solution is a medical device manufactured by Oculus Innovative Sciences. It received FDA 510(k) clearance on 2016-08-19 under approval number K161034. 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 Microcyn Plus Wound Care Solution?
Microcyn Plus Wound Care Solution is a medical device that received FDA 510(k) clearance on 2016-08-19. It is manufactured by Oculus Innovative Sciences. The 510(k) number is K161034.
When was Microcyn Plus Wound Care Solution approved by the FDA?
Microcyn Plus Wound Care Solution received FDA 510(k) clearance on 2016-08-19, under approval number K161034.
What company makes Microcyn Plus Wound Care Solution?
Microcyn Plus Wound Care Solution is manufactured by Oculus Innovative Sciences.
What is the FDA product code for Microcyn Plus Wound Care Solution?
The FDA product code for Microcyn Plus Wound Care Solution 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.