Golnit Nylon Monofilament Suture— 510(k) K212888

Substantially Equivalent

Antarma, LLC Dba Golnit Sutures

FDA 510(k) clearance K212888 for Golnit Nylon Monofilament Suture, Substantially Equivalent on 2022-03-31. Applicant: Antarma, LLC Dba Golnit Sutures.

Clearance details

Applicant: Antarma, LLC Dba Golnit Sutures
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2021-09-10
Decision date: 2022-03-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.