Cleared Traditional

Renasys Edge

K231939 · Smith & Nephew Medical, Ltd. · General & Plastic Surgery

May 2024

Decision

329d

Days

Class 2

Risk

About This 510(k) Submission

K231939 is an FDA 510(k) clearance for the Renasys Edge, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Smith & Nephew Medical, Ltd. (Hull, GB). The FDA issued a Cleared decision on May 24, 2024, 329 days after receiving the submission on June 30, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number	K231939 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2023
Decision Date	May 24, 2024
Days to Decision	329 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4780
Definition	For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.