Clearance Summary
GOLNIT Non-aborbable PTFE Surgical Suture received FDA 510(k) clearance under submission number K192088, sponsored by Antarma, LLC Dba Golnit Sutures. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-09-04.
- Submission: K192088
- Applicant / Sponsor: Antarma, LLC Dba Golnit Sutures
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5035
- Decision date: 2019-09-04
Classification & Regulation
This clearance is catalogued under FDA product code NBY and 21 CFR 878.5035, within the General, Plastic Surgery review panel as a Class II device.