Antibacterial Gel Wound Dressing
K-Number: K231057 · 2023-12-01
ApplicantWinner Medical Co., Ltd.
Decision Date2023-12-01
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Antibacterial Gel Wound Dressing is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-01 under approval number K231057. 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 Antibacterial Gel Wound Dressing?
Antibacterial Gel Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K231057.
When was Antibacterial Gel Wound Dressing approved by the FDA?
Antibacterial Gel Wound Dressing received FDA 510(k) clearance on 2023-12-01, under approval number K231057.
What company makes Antibacterial Gel Wound Dressing?
Antibacterial Gel Wound Dressing is manufactured by Winner Medical Co., Ltd..
What is the FDA product code for Antibacterial Gel Wound Dressing?
The FDA product code for Antibacterial Gel Wound Dressing is FRO. This falls under the Anesthesiology category.
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Related PubMed Literature
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Other Devices by Winner Medical Co., Ltd.
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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.