PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,— 510(k) K141017
Substantially EquivalentKci USA, Inc. (Kinetic Concepts, Inc.)
FDA 510(k) clearance K141017 for PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,, Substantially Equivalent on 2015-08-20. 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
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code OMP
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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 ...
- K133232 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
- K123878 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.