NEW · Class II · 21 CFR 878.4840

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

Leading manufacturers include Ethicon, Inc., Surgical Specialties Corp and Hans Biomed Corporation.

67
Total
67
Cleared
154d
Avg days
2001
Since
67 devices
25–48 of 67
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 Mar 02, 2017
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
K161737
Myco Medical
General & Plastic Surgery · 252d
Cleared Nov 23, 2016
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
K160705
Y. Jacobs Medical, Inc.
General & Plastic Surgery · 254d
Cleared Nov 22, 2016
DW-1C
K160761
Dongwon Medical Co., Ltd.
General & Plastic Surgery · 246d
Cleared May 19, 2016
Filbloc
K150553
Assut Europe
General & Plastic Surgery · 442d
Cleared Sep 11, 2015
J+PRAS YOUNG'S Thread
K143413
Y. Jacobs Medical, Inc.
General & Plastic Surgery · 287d
Cleared Jul 02, 2015
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
K150670
Ethicon, Inc.
General & Plastic Surgery · 108d
Cleared Oct 15, 2014
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776
Ethicon, Inc.
General & Plastic Surgery · 105d
Cleared Nov 29, 2013
TRANQUILL BARBED DEVICE
K133420
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 21d
Cleared Aug 23, 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K132268
Surgical Specialties Corporation Dba Angiotech
General & Plastic Surgery · 32d
Cleared Jun 12, 2013
MINT
K130191
Hans Biomed Corporation
General & Plastic Surgery · 138d
Cleared Feb 26, 2013
ORTHOCORD
K123668
Depuy Mitek, Inc., A Johnson and Johnson Company
General & Plastic Surgery · 89d
Cleared Jan 02, 2013
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K123877
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 16d
Cleared Jul 13, 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
K120827
Angiotech
General & Plastic Surgery · 116d
Cleared May 23, 2012
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284
Coloplast A/S
General & Plastic Surgery · 113d
Cleared Feb 01, 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)
K113744
Angiotech
General & Plastic Surgery · 43d
Cleared Dec 20, 2011
PDS(TM) BARBED SUTURES
K113004
Ethicon, Inc.
General & Plastic Surgery · 74d
Cleared Dec 14, 2010
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
K100780
Unilene Sac
General & Plastic Surgery · 270d
Cleared Jul 08, 2010
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
K100461
Riverpoint Medical
General & Plastic Surgery · 140d
Cleared Jan 08, 2010
DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
K082097
Demetech Corp.
General & Plastic Surgery · 533d
Cleared Jun 09, 2008
PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
K081001
Sutures India Pvt., Ltd.
General & Plastic Surgery · 62d
Cleared Apr 30, 2008
WG-SURGICAL SUTURES WITH NEEDLE
K073614
Foosin Medical Supplies, Inc.
General & Plastic Surgery · 126d