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FDA 510(k)

MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER

K-Number: K102659 · 2010-12-08

ApplicantManuka Medical Limited
Decision Date2010-12-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER 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 2010-12-08 under 510(k) number K102659. 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 MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER?

MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER is a medical device that received FDA 510(k) clearance on 2010-12-08. The listed applicant is Manuka Medical Limited. The 510(k) number is K102659.

When did MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER receive FDA 510(k) clearance?

MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER received FDA 510(k) clearance on 2010-12-08, under 510(k) number K102659.

Who is the listed applicant for MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER?

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 MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER?

The FDA product code for MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER is FRO. This falls under the Anesthesiology category.

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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.

K110042MANUKATEXK092689MANUKAPLI 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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