K063603

Substantially Equivalent

SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17

Applicant: Suturtek Incorporated
Product code: GAQ
Advisory panel: General, Plastic Surgery
Date received: 2006-12-03
Decision date: 2007-02-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Acton, MA, US

Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.