Clearance Summary
1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture received FDA 510(k) clearance under submission number K232246, sponsored by M/s. Meril Endo Surgery Private Limited.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-04-25.
- Submission: K232246
- Applicant / Sponsor: M/s. Meril Endo Surgery Private Limited.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4840
- Decision date: 2024-04-25
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.