← Back to catalogue

Prevena Restor Incision Management System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181507

by Kci Usa, Inc.

Identifiers

510(k) Number
K181507 FDA 510(k)
FDA Product Code
OMP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Prevena Restor Incision Management System is a negative pressure wound therapy device designed to manage surgical incisions that continue to drain after sutured or stapled closure. It maintains a closed environment around the incision while applying negative pressure to remove exudate, promoting optimal healing conditions for closed incisions and surrounding soft tissue.

This system is intended for single-use and is supplied as a portable, sterile kit. It is classified as a Class II medical device under FDA regulations (21 CFR 878.4780) and has received FDA 510(k) clearance (K181507) as substantially equivalent to a predicate device. The system is intended for use in clinical settings where incision management is required, adhering to standard sterile procedures and regulatory compliance standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K181507 PREVENA RESTOR 510k Summary 08Feb2019, 3M Prevena Therapy | Solventum, 3M™ Prevena Restor™ Bella•Form™ Incision Management System, 3M™ Prevena™ Incision Management System - WoundSource

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kci Usa, Inc.

Sources (1)

  • FDA 510(k) K181507 24 fields · synced Sep 20, 2026