Product code NEW
- Device name
- Suture, Surgical, Absorbable, Polydioxanone
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4840
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N18331S027 | PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED | ETHICON, Inc. | 1997-05-12 |
| N18331S025 | PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED | ETHICON, Inc. | 1995-11-02 |
| N18331S026 | PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED | ETHICON, Inc. | 1995-09-07 |
| N18331S024 | PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED | ETHICON, Inc. | 1994-12-21 |
| N18331S023 | PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED | ETHICON, Inc. | 1993-12-09 |
| N18331S022 | PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED | ETHICON, Inc. | 1990-03-20 |
| N18331S021 | PDS SUTURE (DYED) | ETHICON, Inc. | 1989-05-17 |
| N18331S020 | PDS SUTURE (DYED) | ETHICON, Inc. | 1987-10-05 |
| N18331S019 | PDS SUTURE (DYED) | ETHICON, Inc. | 1987-08-28 |
| N18331S018 | PDS SUTURE (DYED) | ETHICON, Inc. | 1987-06-18 |
| N18331S017 | PDS SUTURE (DYED) | ETHICON, Inc. | 1986-12-03 |
| N18331S016 | PDS SUTURE (DYED) | ETHICON, Inc. | 1986-06-06 |
| N18331S012 | PDS SUTURE (DYED) | ETHICON, Inc. | 1984-09-06 |
| N18331S015 | PDS SUTURE (DYED) | ETHICON, Inc. | 1984-06-05 |
| N18331S009 | PDS SUTURE (DYED) | ETHICON, Inc. | 1984-05-02 |
| N18331S013 | PDS SUTURE (DYED) | ETHICON, Inc. | 1984-03-27 |
| N18331S014 | PDS SUTURE (DYED) | ETHICON, Inc. | 1983-11-23 |
| N18331S011 | PDS SUTURE (DYED) | ETHICON, Inc. | 1983-04-18 |
| N18331S010 | PDS SUTURE (DYED) | ETHICON, Inc. | 1983-04-04 |
| N18331S008 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-12-22 |
| N18331S007 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-07-21 |
| N18331S006 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-07-14 |
| N18331S004 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-05-21 |
| N18331S003 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-04-05 |
| N18331S002 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-04-05 |
| N18331S005 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-03-15 |
| N18331S001 | PDS SUTURE (DYED) | ETHICON, Inc. | 1982-01-28 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2026-05-18 |
| K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2025-11-12 |
| K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025-10-20 |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | 2025-10-15 |
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | 2025-09-23 |
| K250977 | Suture-TOOL System | Suturion AB | 2025-04-28 |
| K242835 | Suture-TOOL System | Suturion AB | 2025-01-22 |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FC... | Hyundae Meditech Co., Ltd. | 2024-09-27 |
| K232246 | 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 | M/s. Meril Endo Surgery Private Limited. | 2024-04-25 |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. | 2024-03-27 |
| K220549 | 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 | Hans Biomed Corporation | 2023-03-07 |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | ETHICON, Inc. | 2022-02-22 |
| K210871 | PDO Max Suture with Dual Needle | Pdo Max, Inc. | 2021-12-17 |
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | 2020-10-20 |
| K192423 | MINT Product Family | Hans Biomed Corporation | 2020-09-09 |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2020-03-25 |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | 2019-11-07 |
| K190264 | Viola | Meditime Co., Ltd. | 2019-08-15 |
| K190245 | PDS Barbed Suture, PDO MAXX Threads | Pdo Max, Inc. | 2019-06-04 |
| K182873 | 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 De... | ETHICON, Inc. | 2019-01-10 |
| K172602 | Miracu | Feeltech Co., Ltd. | 2018-11-14 |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018-08-27 |
| K162366 | Omega VL | Ov World Co., Ltd. | 2018-03-02 |
| K161737 | RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed | Myco Medical | 2017-03-02 |
| K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, | Y. Jacobs Medical, Inc. | 2016-11-23 |
| K160761 | DW-1C | Dongwon Medical Co., Ltd. | 2016-11-22 |
| K150553 | Filbloc | Assut Europe | 2016-05-19 |
| K143413 | J+PRAS YOUNG'S Thread | Y. Jacobs Medical, Inc. | 2015-09-11 |
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015-07-02 |
| K141776 | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES | ETHICON, Inc. | 2014-10-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800256051397 | VIOLA | MEDITIME CO., LTD. | 2026-04-07 |
| 08800256051090 | LES ENCRES | MEDITIME CO., LTD. | 2024-06-19 |
| 08800145507851 | Miracu LSCO 19Gx45mm (FCL) | Feeltech Co.,Ltd. | 2023-12-04 |
| 07757093018698 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093683995 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093218357 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019787 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019763 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019626 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019534 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019510 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019350 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019268 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019015 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093018902 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093018612 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 07757093019596 | SUTUMED | Unilene S.A.C. | 2023-01-06 |
| 08809779586492 | MINT | Hans Biomed Corp. | 2022-05-12 |
| 08809779586485 | MINT | Hans Biomed Corp. | 2022-05-12 |
| 08809779585921 | MINT | Hans Biomed Corp. | 2022-01-25 |
| 08809779585938 | MINT | Hans Biomed Corp. | 2022-01-25 |
| 08809779585907 | MINT | Hans Biomed Corp. | 2022-01-03 |
| 08809779585914 | MINT | Hans Biomed Corp. | 2022-01-03 |
| 08809779584542 | MINT | Hans Biomed Corp. | 2021-01-11 |
| 08809556174461 | MINT | Hans Biomed Corp. | 2020-04-07 |
| 08809556174324 | MINT | Hans Biomed Corp. | 2020-03-23 |
| 08809556174331 | MINT | Hans Biomed Corp. | 2020-03-23 |
| 08809556174416 | MINT | Hans Biomed Corp. | 2020-03-23 |
| 08809556174317 | MINT | Hans Biomed Corp. | 2020-03-23 |
| 08809556174294 | MINT | Hans Biomed Corp. | 2020-03-23 |