ConvaVAC Negative Pressure Wound Therapy System— 510(k) K253263

Name: FDA 510(k) clearance K253263
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Substantially Equivalent

Convatec 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.

Clearance details

Applicant: Convatec Limited, Gdc Building
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2025-09-29
Decision date: 2026-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deeside, Flintshire, GB

Download summary PDF View on FDA.gov ↗

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K260646 — RENASYS EDGE (66803126)2026-05-27
K261291 — Nisus NPWT Canister 500-mL (CPC-500)2026-05-21
K254019 — Wound Geni NPWT System2026-05-04

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, 2020-01-01 through 2026-04-23. 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.