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

About This 510(k) Submission

K232246 is an FDA 510(k) clearance for the 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, 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 April 25, 2024, 272 days after receiving the submission on July 28, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.