FDA 510(k)

Skin and Wound Cleanser

K-Number: K231564 · 2023-11-10

Decision Date2023-11-10

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-11-10 under 510(k) number K231564. 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 Skin and Wound Cleanser?

Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2023-11-10. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K231564.

When did Skin and Wound Cleanser receive FDA 510(k) clearance?

Skin and Wound Cleanser received FDA 510(k) clearance on 2023-11-10, under 510(k) number K231564.

Who is the listed applicant for Skin and Wound Cleanser?

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

What is the FDA product code for Skin and Wound Cleanser?

The FDA product code for Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

Other records listing Winner Medical Co., Ltd. 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.

K252001Collagen Wound Dressing K250082Procedure mask/Surgical mask/Face mask K231057Antibacterial Gel Wound Dressing K231152Collagen Wound Dressing K221311Antibacterial Bandage K223232Procedure mask/Surgical mask/Face mask

View all 18 devices →

Related Devices (Code: FRO)

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K261023Microdacyn 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.