Clearance Summary
MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture received FDA 510(k) clearance under submission number K172659, sponsored by M/s. Meril Endo Surgery Private Limited.. 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 2017-09-28.
- Submission: K172659
- Applicant / Sponsor: M/s. Meril Endo Surgery Private Limited.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2017-09-28
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.