Home / 510(k) Clearances / K190264

510(k) K190264

Viola by Meditime Co., Ltd. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2019
Date Received
February 8, 2019
Clearance Type
Traditional
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 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)
  • K252644 — PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PIN (September 23, 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)