RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)— 510(k) K261982

Name: FDA 510(k) clearance K261982
Creator: U.S. Food and Drug Administration
Published: 2026-10-23

Substantially Equivalent

Smith & Nephew Medical, Ltd.

FDA 510(k) clearance K261982 for RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747), Substantially Equivalent on 2026-10-23. Applicant: Smith & Nephew Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Medical, Ltd.
Product code: Product code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2026-06-12
Decision date: 2026-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston Upon Hull, GB

Download summary PDF View on FDA.gov ↗

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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.