ACTICOAT Surgical Dressing
K-Number: K153723 · 2016-09-14
ApplicantSmith & Nephew Medical Limited
Decision Date2016-09-14
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
ACTICOAT Surgical Dressing is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2016-09-14 under approval number K153723. 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 ACTICOAT Surgical Dressing?
ACTICOAT Surgical Dressing is a medical device that received FDA 510(k) clearance on 2016-09-14. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K153723.
When was ACTICOAT Surgical Dressing approved by the FDA?
ACTICOAT Surgical Dressing received FDA 510(k) clearance on 2016-09-14, under approval number K153723.
What company makes ACTICOAT Surgical Dressing?
ACTICOAT Surgical Dressing is manufactured by Smith & Nephew Medical Limited.
What is the FDA product code for ACTICOAT Surgical Dressing?
The FDA product code for ACTICOAT Surgical Dressing 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.