PRODEK— 510(k) K953609

Substantially Equivalent for Some Indications

Sutures , Ltd.

FDA 510(k) clearance K953609 for PRODEK, Substantially Equivalent for Some Indications on 1996-01-31. Applicant: Sutures , Ltd..

Clearance details

Applicant: Sutures , Ltd.
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 1995-08-02
Decision date: 1996-01-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ruabon, Wrexham, GB

Download summary PDF View on FDA.gov ↗

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.