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FDA 510(k)

RENASYS EDGE (66803126)

K-Number: K260646 · 2026-05-27

ApplicantSmith & Nephew Medical, Ltd.
Decision Date2026-05-27
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RENASYS EDGE (66803126) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K260646. 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 2026-05-27. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K260646.

When did RENASYS EDGE (66803126) receive FDA 510(k) clearance?

RENASYS EDGE (66803126) received FDA 510(k) clearance on 2026-05-27, under 510(k) number K260646.

Who is the listed applicant for RENASYS EDGE (66803126)?

The FDA 510(k) record lists Smith & Nephew Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS EDGE (66803126)?

The FDA product code for RENASYS EDGE (66803126) is OMP.

Other records listing Smith & Nephew Medical, 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.

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