AC5 Topical Gel
K-Number: K190129 · 2020-03-11
ApplicantArch Therapeutics, Inc.
Decision Date2020-03-11
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
AC5 Topical Gel is a medical device manufactured by Arch Therapeutics, Inc.. It received FDA 510(k) clearance on 2020-03-11 under approval number K190129. 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 AC5 Topical Gel?
AC5 Topical Gel is a medical device that received FDA 510(k) clearance on 2020-03-11. It is manufactured by Arch Therapeutics, Inc.. The 510(k) number is K190129.
When was AC5 Topical Gel approved by the FDA?
AC5 Topical Gel received FDA 510(k) clearance on 2020-03-11, under approval number K190129.
What company makes AC5 Topical Gel?
AC5 Topical Gel is manufactured by Arch Therapeutics, Inc..
What is the FDA product code for AC5 Topical Gel?
The FDA product code for AC5 Topical Gel 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.