Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2016-10-04 under 510(k) 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. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K161897.

When did PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings receive FDA 510(k) clearance?

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

Who is the listed applicant for PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings?

The FDA 510(k) record lists Kci USA, Inc. (Kinetic Concepts, Inc.) as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07770633Negative Pressure Wound Therapy Devices in Total Knee ArthroplastyNOT_YET_RECRUITINGNCT06025253PINTA - Prophylactic Incisional Negative Pressure Therapy for Major AmputationsRECRUITING

Other records listing Kci USA, Inc. (Kinetic Concepts, Inc.) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemK160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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.

↑