Clearance Summary
PDS Barbed Suture, PDO MAXX Threads received FDA 510(k) clearance under submission number K190245, sponsored by Pdo Max, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-06-04.
- Submission: K190245
- Applicant / Sponsor: Pdo Max, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4840
- Decision date: 2019-06-04
Classification & Regulation
This clearance is catalogued under FDA product code NEW and 21 CFR 878.4840, within the General, Plastic Surgery review panel as a Class II device.