510(k) K123878 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
| Applicant | Kci USA, Inc. (Kinetic Concepts, Inc.), San Antonio TX, US |
| Decision | Substantially Equivalent, Jan 15, 2013 |
| Received | Dec 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2014 | KCI USA, INC. PRE1001: Prevena Peel and Place System Kit
Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE1001US: Prevena Peel and Place System Kit (US-ONLY)
Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain follo Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE1055: Prevena Dressing, 5 Pack
Product Usage:
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE1055US: Prevena Dressing, 5 Pack (US-ONLY)
Product Usage:
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following suture Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE2001: Prevena Incision Management Customizable System Box
Product Usage:
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain f Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE2055: Prevena Customizable Dressing 5-Pack
Product Usage:
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following suture Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY)
Product Usage:
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continu Terminated |
OMP | None listed |
| Mar 5, 2014 | KCI USA, INC. PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY)
Product Usage:
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain foll Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.