SUTURE FIXATION DEVICE; MESH FIXATION DEVICE— 510(k) K021834

Substantially Equivalent

Mle, Inc.

FDA 510(k) clearance K021834 for SUTURE FIXATION DEVICE; MESH FIXATION DEVICE, Substantially Equivalent on 2002-08-28. Applicant: Mle, Inc..

Clearance details

Applicant: Mle, Inc.
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 2002-06-04
Decision date: 2002-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Grafton, MA, US

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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.