Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
Summary
Winner Medical Co., Ltd. received 510(k) clearance for Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use), a FRO device. Cleared on 2021-10-19.
Details
Source
510(k) Clearance
External ID
K202982
Action Date
2021-10-19
Status
Traditional
Category
device
Product Code
FRO
Product Description
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use). Product code: FRO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Winner Medical Co., Ltd. has received 14 total clearances in our database.
Winner Medical Co., Ltd. has 14 FDA actions in our database, including 14 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Winner Medical Co., Ltd. have FDA actions?
Winner Medical Co., Ltd. has 14 FDA actions in our database, including 0 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K202982" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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