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FDA 510(k)

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)

K-Number: K180643 · 2018-11-23

ApplicantMedcu Technologies , Ltd.
Decision Date2018-11-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is the device name listed in this FDA 510(k) record. The listed applicant is Medcu Technologies , Ltd.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K180643. 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 MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Medcu Technologies , Ltd.. The 510(k) number is K180643.

When did MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) receive FDA 510(k) clearance?

MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) received FDA 510(k) clearance on 2018-11-23, under 510(k) number K180643.

Who is the listed applicant for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

The FDA 510(k) record lists Medcu Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)?

The FDA product code for MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) is FRO. This falls under the Anesthesiology category.

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

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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