Prevena Plus Incision Management System (No Ag); Prevena Plus Duo Incision Management System (No Ag)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190697 FDA 510(k)
- FDA Product Code
- OMP FDA 510(k)
- Models / Variants
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 Plus Incision Management System (No Ag) and Prevena Plus Duo Incision Management System (No Ag) are negative pressure wound therapy powered suction pumps designed to manage the environment of surgical incisions that continue to drain following sutured or staple closure. These systems are intended to aid in reducing the incidence of seroma and, in high-risk patients, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
The device is supplied as a therapy unit with associated dressings for single-use application in clinical settings. It is regulated under FDA 510(k) clearance (K190697) as a Class II medical device with product code OMP and regulation number 878.4780, and is intended for use in general and plastic surgery applications.
Frequently asked questions
What clinical scenarios is the Prevena Plus Incision Management System designed to address specifically?
The Prevena Plus Incision Management System (both No Ag and DUO variants) is designed to manage surgical incisions that continue to drain after being closed with sutures or staples. It is intended to help reduce the risk of seroma formation and, in high-risk patients, lower the incidence of superficial surgical site infections in Class I and Class II wounds. This makes it particularly relevant for general and plastic surgery applications where incision drainage and infection risk are concerns.
Are the Prevena Plus Incision Management Systems single-use or reusable, and how should they be stored?
The Prevena Plus Incision Management Systems are supplied as single-use devices for clinical application. Since they are intended for one-time use, they should be stored in their original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for storage to ensure device integrity until use.
What is the regulatory pathway for the Prevena Plus Incision Management System, and how does it classify the device?
The Prevena Plus Incision Management System is classified as a Class II medical device under FDA regulations, specifically under product code OMP and regulation number 878.4780. It received FDA clearance through a 510(k) submission (K190697) and is considered substantially equivalent to a predicate device. This classification reflects its role as a negative pressure wound therapy-powered suction pump for incision management.
What types of dressings are included with the Prevena Plus Incision Management System, and how do they differ between the No Ag and DUO models?
The Prevena Plus Incision Management System comes with associated dressings tailored for single-use application. The No Ag model is designed for standard incision management without antimicrobial agents, while the DUO model includes an additional component (likely antimicrobial or dual-layered) to enhance infection control in high-risk wounds. Both systems are intended to work with the therapy unit to manage drainage and promote healing.
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: PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO ..., 3M™ Prevena™ Incision Management System - WoundSource, 3M Prevena Therapie Patienteninformation | Solventum, 3M™ Prevena™ Duo Incision Management System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190697 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kci Usa, Inc.
Sources (1)
- FDA 510(k) K190697 24 fields · synced Sep 19, 2026