ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026— 510(k) K090489
Substantially EquivalentKci USA, Inc.
FDA 510(k) clearance K090489 for ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026, Substantially Equivalent on 2009-05-14. Applicant: Kci USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Kci USA, Inc.
- Product code
- Code FTL
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- 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 FTL
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view all- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
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- 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 FTL
product code FTL- Death
- 317
- Injury
- 66,072
- Malfunction
- 1,273
- Other
- 3
- Total
- 67,665
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.