510(k) K030227— SUTURTEK FASTCLOSE SUTURING DEVICE

Substantially Equivalent

Suturtek Incorporated

Clearance details

Applicant: Suturtek Incorporated
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 2003-01-22
Decision date: 2003-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkonton, MA, US

Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.