V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...— 510(k) K160451
Substantially EquivalentKci USA, Inc. (Kinetic Concepts, Inc.)
FDA 510(k) clearance K160451 for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ..., Substantially Equivalent on 2016-06-20. 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
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
- 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
- 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.