510(k) K023030— DEMETECH POLYESTER NONABSORBABLE SUTURE

Substantially Equivalent

Demetech Corp.

Clearance details

Applicant: Demetech Corp.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2002-09-11
Decision date: 2003-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.