AVELLE Negative Pressure Wound Therapy System— 510(k) K180205
Substantially EquivalentConvatec Limited
FDA 510(k) clearance K180205 for AVELLE Negative Pressure Wound Therapy System, Substantially Equivalent on 2018-10-19. Applicant: Convatec Limited. Device class: 2.
Clearance details
- Applicant
- Convatec Limited
- 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
- Deeside, GB
Recent devices under product code OMP
view allMore clearances from Convatec Limited
view all- K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- K250891 — Cure Catheter Insertion Kit (K1) +12 more
- K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- K190114 — Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
- K181206 — GentleCath Glide Intermittent Urinary Catheter
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.