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FDA 510(k)

Renasys Edge

K-Number: K231939 · 2024-05-24

ApplicantSmith & Nephew Medical, Ltd.
Decision Date2024-05-24
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renasys Edge is a medical device manufactured by Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2024-05-24 under approval number K231939. 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?

Renasys Edge is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by Smith & Nephew Medical, Ltd.. The 510(k) number is K231939.

When was Renasys Edge approved by the FDA?

Renasys Edge received FDA 510(k) clearance on 2024-05-24, under approval number K231939.

What company makes Renasys Edge?

Renasys Edge is manufactured by Smith & Nephew Medical, Ltd..

What is the FDA product code for Renasys Edge?

The FDA product code for Renasys Edge is OMP.

Other Devices by Smith & Nephew Medical, Ltd.

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Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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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