510(k) K141007— DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE

Substantially Equivalent

Demetech Corp.

Clearance details

Applicant: Demetech Corp.
Product code: Code GAQ
Advisory panel: General, Plastic Surgery
Date received: 2014-04-18
Decision date: 2014-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, 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.