510(k) K990432— SURGISORB

Substantially Equivalent for Some Indications

Sutures , Ltd.

Clearance details

Applicant: Sutures , Ltd.
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 1999-02-11
Decision date: 1999-05-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ruabon, Wrexham, GB

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.