PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING— 510(k) K123878
Substantially EquivalentKci USA, Inc. (Kinetic Concepts, Inc.)
FDA 510(k) clearance K123878 for PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, Substantially Equivalent on 2013-01-15. Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.). Device class: 2.
Clearance details
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Antonio, TX, US
Recent devices under product code OMP
view allMore clearances from Kci USA, Inc. (Kinetic Concepts, Inc.)
view all- K162790 — V.A.C.ULTA Negative Pressure Wound Therapy System
- K161897 — PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
- K160451 — V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
- K141017 — PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
- K133232 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K123878
K-number listed on FDA's recall record- Z-1135-2014 — 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 or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1136-2014 — 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 following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1137-2014 — 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 closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1138-2014 — 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 sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1139-2014 — 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 following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1140-2014 — 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 sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1141-2014 — 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 continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
- Z-1142-2014 — 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 following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123878.
Data sourced from openFDA. This site is unofficial and independent of the FDA.