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

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K232246 ↗

FDA Product Code

NEW

Models / Variants

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

Device Class

Class II

Regulation

21 CFR Part 878.4840

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Mirus Ligating Clip, Mirus Ligating Clip Applier

  Class II

  FDA 510(k) K200166 Active Cleared 23 Nov 2020

• Meristeel

  Class II

  FDA 510(k) K172146 Active Cleared 1 Feb 2018

• FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

  Class II

  FDA 510(k) K160623 Active Cleared 31 May 2016

• 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

  Class II

  FDA 510(k) K172659 Active Cleared 28 Sep 2017

• Meril-Bonewax

  Unclassified

  FDA 510(k) K200452 Active Cleared 27 Mar 2023

• Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

  Class II

  FDA 510(k) K200320 Active Cleared 5 Feb 2021

See all devices from M/s. Meril Endo Surgery Private Limited. →