510(k) K181822— RENASYS Touch; RENASYS Y-Connector

Substantially Equivalent

Smith & Nephew Medical Limited

Clearance details

Applicant: Smith & Nephew Medical Limited
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2018-07-09
Decision date: 2019-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hull, GB

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.