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FDA 510(k)

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

K-Number: K161897 · 2016-10-04

ApplicantKci USA, Inc. (Kinetic Concepts, Inc.)
Decision Date2016-10-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is a medical device manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2016-10-04 under approval number K161897. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is a medical device that received FDA 510(k) clearance on 2016-10-04. It is manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K161897.

When was PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings approved by the FDA?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings received FDA 510(k) clearance on 2016-10-04, under approval number K161897.

What company makes PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.).

What is the FDA product code for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

The FDA product code for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings is OMP.

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Related PubMed Literature

PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41664745 Study of Adverse Events Associated With the Use of Medical Devices Reported Under the Materiovigilance Programme of India in a Tertiary Care Teaching Hospital. Cureus (2026) PMID: 41524152 Securing data management systems in perfusion: A narrative review on cybersecurity and clinical risk. Perfusion (2026)

Other Devices by Kci USA, Inc. (Kinetic Concepts, Inc.)

K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... K162790V.A.C.ULTA Negative Pressure Wound Therapy System

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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