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FDA 510(k)

Extra Silver Gelling Fiber Dressing

K-Number: K221720 · 2022-12-21

ApplicantWinner Medical Co., Ltd.
Decision Date2022-12-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Extra Silver Gelling Fiber Dressing is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under approval number K221720. 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 Extra Silver Gelling Fiber Dressing?

Extra Silver Gelling Fiber Dressing is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K221720.

When was Extra Silver Gelling Fiber Dressing approved by the FDA?

Extra Silver Gelling Fiber Dressing received FDA 510(k) clearance on 2022-12-21, under approval number K221720.

What company makes Extra Silver Gelling Fiber Dressing?

Extra Silver Gelling Fiber Dressing is manufactured by Winner Medical Co., Ltd..

What is the FDA product code for Extra Silver Gelling Fiber Dressing?

The FDA product code for Extra 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.

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