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FDA 510(k)

Microlyte Ag

K-Number: K153756 · 2016-08-04

ApplicantImbed Biosciences, Inc.
Decision Date2016-08-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Microlyte Ag is the device name listed in this FDA 510(k) record. The listed applicant is Imbed Biosciences, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153756. 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?

Microlyte Ag is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Imbed Biosciences, Inc.. The 510(k) number is K153756.

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

Microlyte Ag received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153756.

Who is the listed applicant for Microlyte Ag?

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

What is the FDA product code for Microlyte Ag?

The FDA product code for Microlyte Ag 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, Inc. 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.

K211943Microlyte Ag/Lidocaine

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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