510(k) K040232— LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999

Substantially Equivalent

Lsi Solutions

Clearance details

Applicant: Lsi Solutions
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2004-02-02
Decision date: 2004-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Victor, NY, US

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.