Suture, Surgical, Absorbable, Polydioxanone

FDA product code NEW · 64 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4840
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2001-11-16 – 2026-09-18

NEW 2026-09-18

MINT MONO Sutures

Applicant Hans Biomed Corporation

K number K254238

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NEW 2026-08-25

MONOFIX PDO

Applicant Samyang Holdings Corporation

K number K253879

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NEW 2026-07-09

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

Applicant Teleflex Medical, LLC

K number K261988

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NEW 2026-06-12

Barbed PDO Suture

Applicant Sutura Medical Technology, Inc.

K number K252171

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NEW 2026-05-18

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices

Applicant ETHICON, Inc.

K number K252047

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NEW 2025-11-12

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

Applicant ETHICON, Inc.

K number K243897

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NEW 2025-10-20

Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

Applicant Feeltech Co., Ltd.

K number K251414

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NEW 2025-10-15

V-soft Line™ Barbed Surgical Suture (Various)

Applicant Feeltech Co., Ltd.

K number K250107

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NEW 2025-09-23

PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K number K252644

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NEW 2025-04-28

Suture-TOOL System

Applicant Suturion AB

K number K250977

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NEW 2025-01-22

Suture-TOOL System

Applicant Suturion AB

K number K242835

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NEW 2024-09-27

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

Applicant Hyundae Meditech Co., Ltd.

K number K242571

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NEW 2024-04-25

1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K number K232246

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NEW 2024-03-27

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

Applicant Hyundae Meditech Co., Ltd.

K number K240389

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NEW 2023-03-07

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

Applicant Hans Biomed Corporation

K number K220549

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NEW 2022-02-22

PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture

Applicant ETHICON, Inc.

K number K212380

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NEW 2021-12-17

PDO Max Suture with Dual Needle

Applicant Pdo Max, Inc.

K number K210871

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NEW 2020-10-20

WEGO-PDO Barbed Suture

Applicant Foosin Medical Supplies Inc., Ltd.

K number K201139

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NEW 2020-09-09

MINT Product Family

Applicant Hans Biomed Corporation

K number K192423

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NEW 2020-03-25

STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

Applicant ETHICON, Inc.

K number K192144

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NEW 2019-11-07

DemeDIOX Barbed Absorbable Surgical Suture

Applicant Demetech Corporation

K number K191361

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NEW 2019-08-15

Viola

Applicant Meditime Co., Ltd.

K number K190264

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NEW 2019-06-04

PDS Barbed Suture, PDO MAXX Threads

Applicant Pdo Max, Inc.

K number K190245

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NEW 2019-01-10

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

Applicant ETHICON, Inc.

K number K182873

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NEW 2018-11-14

Miracu

Applicant Feeltech Co., Ltd.

K number K172602

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NEW 2018-08-27

DemeTECH DemeDIOX absorbable surgical suture

Applicant Demetech Corporation

K number K181582

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NEW 2018-03-02

Omega VL

Applicant Ov World Co., Ltd.

K number K162366

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NEW 2017-03-02

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed

Applicant Myco Medical

K number K161737

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NEW 2016-11-23

Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,

Applicant Y. Jacobs Medical, Inc.

K number K160705

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NEW 2016-11-22

DW-1C

Applicant Dongwon Medical Co., Ltd.

K number K160761

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NEW 2016-05-19

Filbloc

Applicant Assut Europe

K number K150553

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NEW 2013-11-29

TRANQUILL BARBED DEVICE

Applicant Surgical Specialties Corp. Dba Angiotech

K number K133420

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NEW 2013-08-23

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Applicant Surgical Specialties Corporation Dba Angiotech

K number K132268

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NEW 2013-06-12

MINT

Applicant Hans Biomed Corporation

K number K130191

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NEW 2013-02-26

ORTHOCORD

Applicant Depuy Mitek, Inc., A Johnson and Johnson Company

K number K123668

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NEW 2013-01-02

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Applicant Surgical Specialties Corp. Dba Angiotech

K number K123877

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NEW 2012-07-13

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)

Applicant Angiotech

K number K120827

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NEW 2012-05-23

DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

Applicant Coloplast A/S

K number K120284

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NEW 2012-02-01

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)

Applicant Angiotech

K number K113744

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NEW 2011-12-20

PDS(TM) BARBED SUTURES

Applicant ETHICON, Inc.

K number K113004

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NEW 2010-12-14

VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

Applicant Unilene Sac

K number K100780

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NEW 2010-07-08

PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT

Applicant Riverpoint Medical

K number K100461

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NEW 2010-01-08

DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE

Applicant Demetech Corp.

K number K082097

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NEW 2008-06-09

PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE

Applicant Sutures India Pvt., Ltd.

K number K081001

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NEW 2008-04-30

WG-SURGICAL SUTURES WITH NEEDLE

Applicant Foosin Medical Supplies, Inc.

K number K073614

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NEW 2008-04-23

QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)

Applicant Surgical Specialties Corp

K number K080985

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NEW 2008-04-23

DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0

Applicant Depuy Mitek

K number K080918

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NEW 2008-03-21

QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE

Applicant Surgical Specialties Corp

K number K080680

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NEW 2007-08-06

QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL

Applicant Surgical Specialties Corp

K number K071989

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NEW 2007-05-09

SHARPOINT PDO (POLYDIOXANONE) SUTURES

Applicant Surgical Specialties Corp

K number K063680

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NEW 2006-07-14

PDS PLUS ANTIBACTERIAL SUTURE

Applicant ETHICON, Inc.

K number K061037

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NEW 2006-01-18

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE

Applicant Surgical Specialties Corp

K number K053380

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NEW 2005-08-04

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

Applicant Quill Medical, Inc.

K number K051609

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NEW 2004-12-10

BLUE ORTHOCORD SUTURE

Applicant Depuy Mitek

K number K043298

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NEW 2004-12-10

UNICRYL M

Applicant United Medical Industries Co. , Ltd.

K number K042285

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NEW 2004-10-26

QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

Applicant Quill Medical, Inc.

K number K042075

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NEW 2004-06-04

POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant Internacional Farmaceutica, S.A. DE C.V.

K number K041048

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NEW 2004-04-13

ORTHOCORD SUTURE

Applicant Depuy Mitek

K number K040004

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NEW 2003-07-17

MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE

Applicant Aesculap

K number K031216

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NEW 2003-06-18

LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS

Applicant Lsi Solutions

K number K031443

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NEW 2003-05-06

MONO-SWIFT

Applicant Cp Medical

K number K030786

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NEW 2003-03-27

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant Genzyme Biosurgery

K number K030212

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NEW 2002-10-09

PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.

Applicant Arc Medical Supplies (Beijing) Co, Ltd.

K number K022666

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NEW 2001-11-16

MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE

Applicant Cp Medical

K number K013274

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