VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100— 510(k) K091585
Substantially EquivalentKci USA, Inc.
FDA 510(k) clearance K091585 for VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100, Substantially Equivalent on 2009-12-29. Applicant: Kci USA, Inc.. Device class: 2.
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
- 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- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System
- K200390 — V.A.C. DERMATAC Drape
- K190697 — PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units
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.