Cleared Traditional

Kendall NPWT Incision Management Dressing Kit

K191101 · Cardinalhealth · General & Plastic Surgery
Jul 2020
Decision
463d
Days
Class 2
Risk

About This 510(k) Submission

K191101 is an FDA 510(k) clearance for the Kendall NPWT Incision Management Dressing Kit, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on July 31, 2020, 463 days after receiving the submission on April 25, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K191101 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2019
Decision Date July 31, 2020
Days to Decision 463 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.

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