GRAMS POLYPROPYLENE NONABSORBABLE SUTURE— 510(k) K002999

Substantially Equivalent

Gramsmed, LLC

FDA 510(k) clearance K002999 for GRAMS POLYPROPYLENE NONABSORBABLE SUTURE, Substantially Equivalent on 2000-12-18. Applicant: Gramsmed, LLC.

Clearance details

Applicant: Gramsmed, LLC
Product code: Code GAW
Advisory panel: General, Plastic Surgery
Date received: 2000-09-26
Decision date: 2000-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grafton, WI, US

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.