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RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD - Renasys

by Smith & Nephew, Inc. 510(k)

Active United States

510(k) K110647

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110647 Date22 Jun 2011ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1161-2014 FDA Class II initiated 9 Jan 2014
    • Terminated Z-1162-2014 FDA Class II initiated 9 Jan 2014
    • Terminated Z-1157-2014 FDA Class II initiated 9 Jan 2014
    • Terminated Z-1160-2014 FDA Class II initiated 9 Jan 2014
    • Terminated Z-1158-2014 FDA Class II initiated 9 Jan 2014
    • Terminated Z-1159-2014 FDA Class II initiated 9 Jan 2014

    Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo

Specification

510(k)

510(k) Number
FDA Product Code
OMP
Models / Variants
Renasys
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Foam and Gauze NPWT Wound Dressing Kits are classified as Negative Pressure Wound Therapy (NPWT) devices designed to promote wound healing through controlled suction. These kits deliver negative pressure therapy to the wound bed, facilitating granulation tissue formation, reducing edema, and enhancing perfusion by removing exudate and promoting a moist wound environment.

These kits are supplied as single-use, sterile devices intended for use in clinical settings such as hospitals, surgical centers, and outpatient care. Each kit includes foam or gauze dressings with a suction pad and a soft port for connection to an NPWT pump, ensuring proper sealing and vacuum delivery. The devices are regulated under FDA 510(k) clearance (K110647) and comply with classification under device class 2 (OMP product code). No MRI safety or reusable specifications are indicated.

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