Redermax Antibacterial Wound Matrix
K-Number: K251582 · 2026-02-02
ApplicantBeijing Kreate Medical Co., Ltd.
Decision Date2026-02-02
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Redermax Antibacterial Wound Matrix is a medical device manufactured by Beijing Kreate Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-02 under approval number K251582. 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 Redermax Antibacterial Wound Matrix?
Redermax Antibacterial Wound Matrix is a medical device that received FDA 510(k) clearance on 2026-02-02. It is manufactured by Beijing Kreate Medical Co., Ltd.. The 510(k) number is K251582.
When was Redermax Antibacterial Wound Matrix approved by the FDA?
Redermax Antibacterial Wound Matrix received FDA 510(k) clearance on 2026-02-02, under approval number K251582.
What company makes Redermax Antibacterial Wound Matrix?
Redermax Antibacterial Wound Matrix is manufactured by Beijing Kreate Medical Co., Ltd..
What is the FDA product code for Redermax Antibacterial Wound Matrix?
The FDA product code for Redermax Antibacterial Wound Matrix is FRO. This falls under the Anesthesiology category.
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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.