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Renasys Edge (66803126)

by Smith & Nephew Medical Limited

510(k) K223041

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223041 Date22 Nov 2022ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-0516-2025 FDA Class II initiated 2 Oct 2024

    Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

  • 2 recalls, same reason

    • Ongoing Z-1596-2024 FDA Class II initiated 11 Mar 2024
    • Ongoing Z-1597-2024 FDA Class II initiated 11 Mar 2024

    Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OMP
Device class
Class II
Regulation
21 CFR Part 878.4780
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Renasys Edge (66803126) is a Negative Pressure Wound Therapy Powered Suction Pump. It is classified as a Class II medical device and is substantially equivalent to predicate devices under FDA 510(k) clearance K223041.

The device is supplied by Smith & Nephew Medical Limited and is intended for use in general and plastic surgery settings. It is regulated under FDA regulation number 878.4780 and has been cleared for marketing via the traditional 510(k) pathway.

Other devices from Smith & Nephew Medical, Ltd.

See all devices from Smith & Nephew Medical, Ltd. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Renasys Edge (66803126) used for?

    The Renasys Edge (66803126) is a Negative Pressure Wound Therapy Powered Suction Pump intended for use in general and plastic surgery settings to assist in wound management by applying controlled subatmospheric pressure to the wound site.

  • How is the Renasys Edge (66803126) supplied and by whom?

    The Renasys Edge (66803126) is supplied by Smith & Nephew Medical Limited, located at 101 Hessle Rd., Hull, HU32BN, United Kingdom, as the manufacturer and distributor of the device.

  • Is the Renasys Edge (66803126) a single-use or reusable device?

    The device data does not specify whether the Renasys Edge (66803126) is single-use or reusable; therefore, no determination can be made about its reusability based solely on the provided information.

  • What regulatory pathway was used for the Renasys Edge (66803126)?

    The Renasys Edge (66803126) was cleared for marketing via the traditional FDA 510(k) pathway, as indicated by its clearance type and authorization under FDA_510K with K-number K223041.

  • What is the device classification and regulation number for the Renasys Edge (66803126)?

    The Renasys Edge (66803126) is classified as a Class II medical device and is regulated under FDA regulation number 878.4780, which corresponds to negative pressure wound therapy devices.