Silver Gelling Fiber Dressing
K-Number: K210466 · 2022-01-14
ApplicantWinner Medical Co., Ltd.
Decision Date2022-01-14
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Silver Gelling Fiber Dressing is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under approval number K210466. 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 Silver Gelling Fiber Dressing?
Silver Gelling Fiber Dressing is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K210466.
When was Silver Gelling Fiber Dressing approved by the FDA?
Silver Gelling Fiber Dressing received FDA 510(k) clearance on 2022-01-14, under approval number K210466.
What company makes Silver Gelling Fiber Dressing?
Silver Gelling Fiber Dressing is manufactured by Winner Medical Co., Ltd..
What is the FDA product code for Silver Gelling Fiber Dressing?
The FDA product code for Silver Gelling Fiber Dressing 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.