V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766— 510(k) K063740

Clearance details

Applicant

Kci USA, Inc.

Product code

Code OMP

Device class

Class 2

Regulation

21 CFR 878.4780

Advisory panel

General, Plastic Surgery

Date received

2006-12-18

Decision date

2007-06-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Antonio, TX, US

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• K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)2024-05-23
• K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System2020-07-08
• K200390 — V.A.C. DERMATAC Drape2020-05-18
• K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)2019-11-22
• DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units2019-04-19

Death

31

Injury

1,707

Malfunction

4,047

Other

1

Total

5,786

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2171-2017 — 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canisterClass II·Terminated·KCI USA, INC.·20170428

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063740.