K983108

Substantially Equivalent

SUTURE WELDING SYSTEM AND KIT (SWK)

Applicant: Axya Medical, Inc.
Product code: GAW
Advisory panel: General, Plastic Surgery
Date received: 1998-09-04
Decision date: 1998-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.