Microlyte Ag/Lidocaine
K-Number: K211943 · 2024-10-17
Device Summary
Microlyte Ag/Lidocaine is a medical device manufactured by Imbed Biosciences. It received FDA 510(k) clearance on 2024-10-17 under approval number K211943. 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 Microlyte Ag/Lidocaine?
Microlyte Ag/Lidocaine is a medical device that received FDA 510(k) clearance on 2024-10-17. It is manufactured by Imbed Biosciences. The 510(k) number is K211943.
When was Microlyte Ag/Lidocaine approved by the FDA?
Microlyte Ag/Lidocaine received FDA 510(k) clearance on 2024-10-17, under approval number K211943.
What company makes Microlyte Ag/Lidocaine?
Microlyte Ag/Lidocaine is manufactured by Imbed Biosciences.
What is the FDA product code for Microlyte Ag/Lidocaine?
The FDA product code for Microlyte Ag/Lidocaine 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.