Cleared Special

Suture-TOOL System

K250977 · Suturion AB · General & Plastic Surgery
Apr 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K250977 is an FDA 510(k) clearance for the Suture-TOOL System, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Suturion AB (Lund, SE). The FDA issued a Cleared decision on April 28, 2025, 28 days after receiving the submission on March 31, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.

Submission Details

510(k) Number K250977 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2025
Decision Date April 28, 2025
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code NEW — Suture, Surgical, Absorbable, Polydioxanone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4840

Similar Devices — NEW Suture, Surgical, Absorbable, Polydioxanone

All 61
PDS? Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897 · Ethicon, Inc. · Nov 2025
Miracu? Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · Feeltech Co., Ltd. · Oct 2025
V-soft Line? Barbed Surgical Suture (Various)
K250107 · Feeltech Co., Ltd. · Oct 2025
PINION? PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION? PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
K252644 · M/s. Meril Endo Surgery Private Limited. · Sep 2025
Suture-TOOL System
K242835 · Suturion AB · Jan 2025
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
K242571 · Hyundae Meditech Co., Ltd. · Sep 2024