TroClose1200— 510(k) K160564

Substantially Equivalent

Gordian Surgical, Ltd.

FDA 510(k) clearance K160564 for TroClose1200, Substantially Equivalent on 2016-11-17. Applicant: Gordian Surgical, Ltd..

Clearance details

Applicant: Gordian Surgical, Ltd.
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2016-02-29
Decision date: 2016-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Karmiel, IL

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Adverse events under product code GAM

product code GAM

Death: 45
Injury: 5,711
Malfunction: 30,744
Other: 4
Total: 36,504

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.