Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
Summary
Smith & Nephew Medical Limited received 510(k) clearance for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing, a OMP device. Cleared on 2022-01-14.
Details
Source
510(k) Clearance
External ID
K202783
Action Date
2022-01-14
Status
Traditional
Category
device
Product Code
OMP
Product Description
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing. Product code: OMP.
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. Smith & Nephew Medical Limited has received 6 total clearances in our database.
Smith & Nephew Medical Limited has 6 FDA actions in our database, including 6 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 Smith & Nephew Medical Limited have FDA actions?
Smith & Nephew Medical Limited has 6 FDA actions in our database, including 0 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K202783" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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