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FDA 510(k)

Renasys Edge (66803126)

K-Number: K223041 · 2022-11-22

ApplicantSmith & Nephew Medical Limited
Decision Date2022-11-22
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renasys Edge (66803126) is a medical device manufactured by Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2022-11-22 under approval number K223041. 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 Edge (66803126)?

Renasys Edge (66803126) is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Smith & Nephew Medical Limited. The 510(k) number is K223041.

When was Renasys Edge (66803126) approved by the FDA?

Renasys Edge (66803126) received FDA 510(k) clearance on 2022-11-22, under approval number K223041.

What company makes Renasys Edge (66803126)?

Renasys Edge (66803126) is manufactured by Smith & Nephew Medical Limited.

What is the FDA product code for Renasys Edge (66803126)?

The FDA product code for Renasys Edge (66803126) 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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