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FDA 510(k)

MANUKATEX

K-Number: K110042 · 2011-03-24

ApplicantManuka Medical Limited
Decision Date2011-03-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MANUKATEX is the device name listed in this FDA 510(k) record. The listed applicant is Manuka Medical Limited. It received FDA 510(k) clearance on 2011-03-24 under 510(k) number K110042. 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 MANUKATEX?

MANUKATEX is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Manuka Medical Limited. The 510(k) number is K110042.

When did MANUKATEX receive FDA 510(k) clearance?

MANUKATEX received FDA 510(k) clearance on 2011-03-24, under 510(k) number K110042.

Who is the listed applicant for MANUKATEX?

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

What is the FDA product code for MANUKATEX?

The FDA product code for MANUKATEX 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.

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Other records listing Manuka Medical Limited 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.

K102659MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDERK092689MANUKAPLI WOUND DRESSING

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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.

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