Panels › General, Plastic Surgery › Product code NEW · Class 2
Suture, Surgical, Absorbable, Polydioxanone
Regulation 878.4840
6510(k)s in 12 months (67 all time)
0recalls in 12 months (40 all time)
32recalls that name a 510(k)
Top companies in NEW
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 9 | 24 |
| DePuy Mitek, Inc., a Johnson & Johnson Co. | 0 | 5 |
| Surgical Specialties Corp | 5 | 0 |
| C P Medical | 0 | 4 |
| Ethicon Endo Surgery, LLC | 0 | 4 |
| Hans Biomed Corporation | 4 | 0 |
| Demetech Corp. | 3 | 0 |
| Depuy Mitek | 3 | 0 |
| Feeltech Co., Ltd. | 3 | 0 |
| Surgical Specialties Corp. Dba Angiotech | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K254238 | MINT MONO Sutures Hans Biomed Corporation, KR | NEW |
| Aug 25, 2026 | K253879 | MONOFIX PDO Samyang Holdings Corporation, KR | NEW |
| Jul 9, 2026 | K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture Teleflex Medical, LLC | NEW |
| Jun 12, 2026 | K252171 | Barbed PDO Suture Sutura Medical Technology, Inc. | NEW |
| May 18, 2026 | K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices ETHICON, Inc. | NEW |
| Nov 12, 2025 | K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture ETHICON, Inc. | NEW |
| Oct 20, 2025 | K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO) Feeltech Co., Ltd., KR | NEW |
| Oct 15, 2025 | K250107 | V-soft Line Barbed Surgical Suture (Various) Feeltech Co., Ltd., KR | NEW |
| Sep 23, 2025 | K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbabl M/s. Meril Endo Surgery Private Limited., IN | NEW |
| Apr 28, 2025 | K250977 | Suture-TOOL System Suturion AB, SE | NEW |
| Jan 22, 2025 | K242835 | Suture-TOOL System Suturion AB, SE | NEW |
| Sep 27, 2024 | K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC205 Hyundae Meditech Co., Ltd., KR | NEW |
| Apr 25, 2024 | K232246 | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Abs M/s. Meril Endo Surgery Private Limited., IN | NEW |
| Mar 27, 2024 | K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 Hyundae Meditech Co., Ltd., KR | NEW |
| Mar 7, 2023 | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 101 Hans Biomed Corporation, KR | NEW |
| Feb 22, 2022 | K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture ETHICON, Inc. | NEW |
| Dec 17, 2021 | K210871 | PDO Max Suture with Dual Needle Pdo Max, Inc. | NEW |
| Oct 20, 2020 | K201139 | WEGO-PDO Barbed Suture Foosin Medical Supplies Inc., Ltd., CN | NEW |
| Sep 9, 2020 | K192423 | MINT Product Family Hans Biomed Corporation, KR | NEW |
| Mar 25, 2020 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device ETHICON, Inc. | NEW |
| Nov 7, 2019 | K191361 | DemeDIOX Barbed Absorbable Surgical Suture Demetech Corporation | NEW |
| Aug 15, 2019 | K190264 | Viola Meditime Co., Ltd., KR | NEW |
| Jun 4, 2019 | K190245 | PDS Barbed Suture, PDO MAXX Threads Pdo Max, Inc. | NEW |
| Jan 10, 2019 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, ETHICON, Inc. | NEW |
| Nov 14, 2018 | K172602 | Miracu Feeltech Co., Ltd., KR | NEW |
| Aug 27, 2018 | K181582 | DemeTECH DemeDIOX absorbable surgical suture Demetech Corporation | NEW |
| Mar 2, 2018 | K162366 | Omega VL Ov World Co., Ltd., KR | NEW |
| Mar 2, 2017 | K161737 | RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed Myco Medical | NEW |
| Nov 23, 2016 | K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, Y. Jacobs Medical, Inc., KR | NEW |
| Nov 22, 2016 | K160761 | DW-1C Dongwon Medical Co., Ltd., KR | NEW |
| May 19, 2016 | K150553 | Filbloc Assut Europe, IT | NEW |
| Sep 11, 2015 | K143413 | J+PRAS YOUNG'S Thread Y. Jacobs Medical, Inc., KR | NEW |
| Jul 2, 2015 | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device ETHICON, Inc. | NEW |
| Oct 15, 2014 | K141776 | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES ETHICON, Inc. | NEW |
| Nov 29, 2013 | K133420 | TRANQUILL BARBED DEVICE Surgical Specialties Corp. Dba Angiotech | NEW |
| Aug 23, 2013 | K132268 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corporation Dba Angiotech | NEW |
| Jun 12, 2013 | K130191 | MINT Hans Biomed Corporation | NEW |
| Feb 26, 2013 | K123668 | ORTHOCORD Depuy Mitek, Inc., A Johnson and Johnson Company | NEW |
| Jan 2, 2013 | K123877 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN Surgical Specialties Corp. Dba Angiotech | NEW |
| Jul 13, 2012 | K120827 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) Angiotech | NEW |
| May 23, 2012 | K120284 | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX Coloplast A/S | NEW |
| Feb 1, 2012 | K113744 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) Angiotech | NEW |
| Dec 20, 2011 | K113004 | PDS(TM) BARBED SUTURES ETHICON, Inc. | NEW |
| Dec 14, 2010 | K100780 | VITAL SUTURES, SUTUREX, CIRUGIA PERUANA Unilene Sac | NEW |
| Jul 8, 2010 | K100461 | PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT Riverpoint Medical | NEW |
| Jan 8, 2010 | K082097 | DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE Demetech Corp. | NEW |
| Jun 9, 2008 | K081001 | PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE Sutures India Pvt., Ltd., IN | NEW |
| Apr 30, 2008 | K073614 | WG-SURGICAL SUTURES WITH NEEDLE Foosin Medical Supplies, Inc., CN | NEW |
| Apr 23, 2008 | K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) Surgical Specialties Corp | NEW |
| Apr 23, 2008 | K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 Depuy Mitek | NEW |
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