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FDA 510(k)

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

K-Number: K202783 · 2022-01-14

ApplicantSmith & Nephew Medical Limited
Decision Date2022-01-14
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2022-01-14 under approval number K202783. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K202783.

When was Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing approved by the FDA?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing received FDA 510(k) clearance on 2022-01-14, under approval number K202783.

What company makes Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is manufactured by Smith & Nephew Medical Limited.

What is the FDA product code for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing?

The FDA product code for Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing is OMP.

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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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