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# KCI Gains De Novo Clearance for Prevena
- URL: https://www.fdaweb.com/kci-gains-de-novo-clearance-for-prevena/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144074

FDA has granted *de novo* marketing clearance to KCI for Prevena Incision Management System, a negative pressure medical device indicated to aid in reducing superficial surgical site infections in patients at a high risk for post-operative infections in Class 1 and 2 wounds. The device is also intended to aid in reducing the incidence of seromas. The company says that Prevena is the “first disposable negative pressure system designed specifically for the management of closed surgical incisions. It covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.”