About This 510(k) Submission
K252644 is an FDA 510(k) clearance for the PINION? PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION? PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by M/s. Meril Endo Surgery Private Limited. (Vapi, IN). The FDA issued a Cleared decision on September 23, 2025, 33 days after receiving the submission on August 21, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.