LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS— 510(k) K031443

Substantially Equivalent

Lsi Solutions

FDA 510(k) clearance K031443 for LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS, Substantially Equivalent on 2003-06-18. Applicant: Lsi Solutions.

Clearance details

Applicant: Lsi Solutions
Product code: Code NEW
Advisory panel: General, Plastic Surgery
Date received: 2003-05-06
Decision date: 2003-06-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Victor, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

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.