OPUS SPEEDSTITCH SUTURE DEVICE— 510(k) K042031

Substantially Equivalent

Opus Medical, Inc.

FDA 510(k) clearance K042031 for OPUS SPEEDSTITCH SUTURE DEVICE, Substantially Equivalent on 2004-10-19. Applicant: Opus Medical, Inc..

Clearance details

Applicant: Opus Medical, Inc.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2004-07-28
Decision date: 2004-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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.