FDA 510(k)

ACTICOAT Surgical Dressing

K-Number: K153723 · 2016-09-14

Decision Date2016-09-14

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

ACTICOAT Surgical Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2016-09-14 under 510(k) 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. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K153723.

When did ACTICOAT Surgical Dressing receive FDA 510(k) clearance?

ACTICOAT Surgical Dressing received FDA 510(k) clearance on 2016-09-14, under 510(k) number K153723.

Who is the listed applicant for ACTICOAT Surgical Dressing?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Smith & Nephew Medical Limited as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.