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FDA 510(k)

Microlyte Ag/Lidocaine

K-Number: K211943 · 2024-10-17

ApplicantImbed Biosciences
Decision Date2024-10-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Microlyte Ag/Lidocaine is the device name listed in this FDA 510(k) record. The listed applicant is Imbed Biosciences. It received FDA 510(k) clearance on 2024-10-17 under 510(k) 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. The listed applicant is Imbed Biosciences. The 510(k) number is K211943.

When did Microlyte Ag/Lidocaine receive FDA 510(k) clearance?

Microlyte Ag/Lidocaine received FDA 510(k) clearance on 2024-10-17, under 510(k) number K211943.

Who is the listed applicant for Microlyte Ag/Lidocaine?

The FDA 510(k) record lists Imbed Biosciences as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07695688Safety Study of Microlyte DualGuardNOT_YET_RECRUITING

Other records listing Imbed Biosciences as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153756Microlyte Ag

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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