Home / 510(k) Clearances / K252644

510(k) K252644

PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture by M/s. Meril Endo Surgery Private Limited. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2025
Date Received
August 21, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by M/s. Meril Endo Surgery Private Limited.

  • K233386 — Monik™ - Disposable Endoscopic Trocar (May 24, 2024)
  • K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; (April 25, 2024)
  • K230981 — Meriglu Topical Skin Adhesive (March 16, 2024)
  • K200452 — Meril-Bonewax (March 27, 2023)
  • K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circu (February 5, 2021)
  • K200166 — Mirus Ligating Clip, Mirus Ligating Clip Applier (November 23, 2020)
  • K172146 — MERISTEEL (February 1, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K172659 — MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorba (September 28, 2017)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)

Other clearances for product code NEW

  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K251414 — Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (October 20, 2025)
  • K250107 — V-soft Line™ Barbed Surgical Suture (Various) (October 15, 2025)
  • K250977 — Suture-TOOL System (April 28, 2025)
  • K242835 — Suture-TOOL System (January 22, 2025)
  • K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 (September 27, 2024)
  • K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; (April 25, 2024)
  • K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (March 27, 2024)
  • K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift M (March 7, 2023)
  • K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu (February 22, 2022)