ConvaVAC Negative Pressure Wound Therapy System— 510(k) K253263
Substantially EquivalentConvatec Limited, Gdc Building
FDA 510(k) clearance K253263 for ConvaVAC Negative Pressure Wound Therapy System, Substantially Equivalent on 2026-06-24. Applicant: Convatec Limited, Gdc Building. Device class: 2.
Summary
Convatec's ConvaVAC Negative Pressure Wound Therapy System is filed under OMP, negative pressure wound therapy powered suction pumps. The record doesn't list the system's components or model numbers.
Class II, 21 CFR 878.4780. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Convatec filed from Deeside, Flintshire, United Kingdom. Review took 268 calendar days (September 29, 2025 to June 24, 2026).
Clearance details
- Applicant
- Convatec Limited, Gdc Building
- Product code
- Product 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, Flintshire, GB
Recent devices under product code OMP
view allAdverse 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.