NEW · Class II · 21 CFR 878.4840

FDA Product Code NEW: Suture, Surgical, Absorbable, Polydioxanone

Leading manufacturers include Ethicon, Inc., Feeltech Co., Ltd. and M/s. Meril Endo Surgery Private Limited..

65
Total
65
Cleared
151d
Avg days
2001
Since
Growing category - 10 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 167d avg (recent)

FDA 510(k) Cleared Suture, Surgical, Absorbable, Polydioxanone Devices (Product Code NEW)

65 devices
1–24 of 65
Cleared May 18, 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047
Ethicon, Inc.
General & Plastic Surgery · 322d
Cleared Nov 12, 2025
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
K243897
Ethicon, Inc.
General & Plastic Surgery · 328d
Cleared Oct 20, 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414
Feeltech Co., Ltd.
General & Plastic Surgery · 166d
Cleared Oct 15, 2025
V-soft Line™ Barbed Surgical Suture (Various)
K250107
Feeltech Co., Ltd.
General & Plastic Surgery · 273d
Cleared Sep 23, 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 33d
Cleared Apr 28, 2025
Suture-TOOL System
K250977
Suturion AB
General & Plastic Surgery · 28d
Cleared Jan 22, 2025
Suture-TOOL System
K242835
Suturion AB
General & Plastic Surgery · 125d
Cleared Sep 27, 2024
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.
General & Plastic Surgery · 29d
Cleared Apr 25, 2024
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K232246
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 272d
Cleared Mar 27, 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389
Hyundae Meditech Co., Ltd.
General & Plastic Surgery · 48d
Cleared Mar 07, 2023
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
K220549
Hans Biomed Corporation
General & Plastic Surgery · 375d
Cleared Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
K212380
Ethicon, Inc.
General & Plastic Surgery · 204d
Cleared Dec 17, 2021
PDO Max Suture with Dual Needle
K210871
Pdo Max, Inc.
General & Plastic Surgery · 268d
Cleared Oct 20, 2020
WEGO-PDO Barbed Suture
K201139
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 175d
Cleared Sep 09, 2020
MINT Product Family
K192423
Hans Biomed Corporation
General & Plastic Surgery · 371d
Cleared Mar 25, 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144
Ethicon, Inc.
General & Plastic Surgery · 230d
Cleared Nov 07, 2019
DemeDIOX Barbed Absorbable Surgical Suture
K191361
Demetech Corporation
General & Plastic Surgery · 170d
Cleared Aug 15, 2019
Viola
K190264
Meditime Co., Ltd.
General & Plastic Surgery · 188d
Cleared Jun 04, 2019
PDS Barbed Suture, PDO MAXX Threads
K190245
Pdo Max, Inc.
General & Plastic Surgery · 118d
Cleared Jan 10, 2019
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
K182873
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Nov 14, 2018
Miracu
K172602
Feeltech Co., Ltd.
General & Plastic Surgery · 441d
Cleared Aug 27, 2018
DemeTECH DemeDIOX absorbable surgical suture
K181582
Demetech Corporation
General & Plastic Surgery · 73d
Cleared Mar 02, 2018
Omega VL
K162366
Ov World Co., Ltd.
General & Plastic Surgery · 556d
Cleared Jul 02, 2015
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
K150670
Ethicon, Inc.
General & Plastic Surgery · 108d

About Product Code NEW - Regulatory Context

510(k) Submission Activity

65 total 510(k) submissions under product code NEW since 2001, with 65 receiving FDA clearance (average review time: 151 days).

Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NEW Product Code

FDA review times for NEW submissions have been consistent, averaging 167 days recently vs 148 days historically.

NEW devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →