K012865

Substantially Equivalent

SUPERSTITCH VASCULAR SUTURING DEVICE

Applicant: Sutura, Inc.
Product code: GAW
Advisory panel: General, Plastic Surgery
Date received: 2001-08-27
Decision date: 2001-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Fountain Valley, CA, 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.