FDA 510(k)

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING

K-Number: K123878 · 2013-01-15

ApplicantKci USA, Inc. (Kinetic Concepts, Inc.)

Decision Date2013-01-15

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING 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 2013-01-15 under 510(k) number K123878. 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 INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING?

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING is a medical device that received FDA 510(k) clearance on 2013-01-15. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K123878.

When did PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING receive FDA 510(k) clearance?

PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING received FDA 510(k) clearance on 2013-01-15, under 510(k) number K123878.

Who is the listed applicant for PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING?

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 INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING?

The FDA product code for PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING is OMP.

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

K162790V.A.C.ULTA Negative Pressure Wound Therapy System K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEM

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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.