FDA 510(k)

Silver Gelling Fiber Dressing

K-Number: K210466 · 2022-01-14

Decision Date2022-01-14

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Silver Gelling Fiber Dressing 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 2022-01-14 under 510(k) 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. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K210466.

When did Silver Gelling Fiber Dressing receive FDA 510(k) clearance?

Silver Gelling Fiber Dressing received FDA 510(k) clearance on 2022-01-14, under 510(k) number K210466.

Who is the listed applicant for Silver Gelling Fiber Dressing?

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 Silver Gelling Fiber Dressing?

The FDA product code for Silver Gelling Fiber Dressing is FRO. This falls under the Anesthesiology category.

Other records listing Winner Medical Co., Ltd. as applicant

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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.