510(k) K163142— SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

Substantially Equivalent

ArthroCare Corporation

Clearance details

Applicant: ArthroCare Corporation
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2016-11-09
Decision date: 2017-01-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, 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.