FDA Product Code
FDA Product Code NEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4840
510(k) Clearances — 67 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254238 | MINT MONO Sutures | Hans Biomed Corporation | 2026-09-18 | Traditional | PDF ↗ |
| K253879 | MONOFIX PDO | Samyang Holdings Corporation | 2026-08-25 | Traditional | PDF ↗ |
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | Teleflex Medical, LLC | 2026-07-09 | Special | PDF ↗ |
| K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | 2026-06-12 | Traditional | PDF ↗ |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2026-05-18 | Traditional | PDF ↗ |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture | ETHICON, Inc. | 2025-11-12 | Traditional | PDF ↗ |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co., Ltd. | 2025-10-20 | Traditional | PDF ↗ |
| K250107 | V-soft Line Barbed Surgical Suture (Various) | Feeltech Co., Ltd. | 2025-10-15 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K250977 | Suture-TOOL System | Suturion AB | 2025-04-28 | Special | PDF ↗ |
| K242835 | Suture-TOOL System | Suturion AB | 2025-01-22 | Traditional | PDF ↗ |
| K242571 | 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 | Hyundae Meditech Co., Ltd. | 2024-09-27 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) | Hyundae Meditech Co., Ltd. | 2024-03-27 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture | ETHICON, Inc. | 2022-02-22 | Traditional | PDF ↗ |
| K210871 | PDO Max Suture with Dual Needle | Pdo Max, Inc. | 2021-12-17 | Traditional | PDF ↗ |
| K201139 | WEGO-PDO Barbed Suture | Foosin Medical Supplies Inc., Ltd. | 2020-10-20 | Traditional | PDF ↗ |
| K192423 | MINT Product Family | Hans Biomed Corporation | 2020-09-09 | Traditional | PDF ↗ |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2020-03-25 | Traditional | PDF ↗ |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | Demetech Corporation | 2019-11-07 | Traditional | PDF ↗ |
| K190264 | Viola | Meditime Co., Ltd. | 2019-08-15 | Traditional | PDF ↗ |
| K190245 | PDS Barbed Suture, PDO MAXX Threads | Pdo Max, Inc. | 2019-06-04 | Abbreviated | PDF ↗ |
| 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 Devices | ETHICON, Inc. | 2019-01-10 | Traditional | PDF ↗ |
| K172602 | Miracu | Feeltech Co., Ltd. | 2018-11-14 | Traditional | PDF ↗ |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | Demetech Corporation | 2018-08-27 | Special | PDF ↗ |
| K162366 | Omega VL | Ov World Co., Ltd. | 2018-03-02 | Traditional | PDF ↗ |
| K161737 | RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed | Myco Medical | 2017-03-02 | Abbreviated | PDF ↗ |
| K160705 | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, | Y. Jacobs Medical, Inc. | 2016-11-23 | Traditional | PDF ↗ |
| K160761 | DW-1C | Dongwon Medical Co., Ltd. | 2016-11-22 | Traditional | PDF ↗ |
| K150553 | Filbloc | Assut Europe | 2016-05-19 | Traditional | PDF ↗ |
| K143413 | J+PRAS YOUNG'S Thread | Y. Jacobs Medical, Inc. | 2015-09-11 | Traditional | PDF ↗ |
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015-07-02 | Traditional | PDF ↗ |
| K141776 | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES | ETHICON, Inc. | 2014-10-15 | Traditional | PDF ↗ |
| K133420 | TRANQUILL BARBED DEVICE | Surgical Specialties Corp. Dba Angiotech | 2013-11-29 | Special | PDF ↗ |
| K132268 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corporation Dba Angiotech | 2013-08-23 | Special | PDF ↗ |
| K130191 | MINT | Hans Biomed Corporation | 2013-06-12 | Traditional | PDF ↗ |
| K123668 | ORTHOCORD | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013-02-26 | Traditional | PDF ↗ |
| K123877 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | Surgical Specialties Corp. Dba Angiotech | 2013-01-02 | Special | PDF ↗ |
| K120827 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) | Angiotech | 2012-07-13 | Traditional | PDF ↗ |
| K120284 | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX | Coloplast A/S | 2012-05-23 | Traditional | PDF ↗ |
| K113744 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) | Angiotech | 2012-02-01 | Traditional | PDF ↗ |
| K113004 | PDS(TM) BARBED SUTURES | ETHICON, Inc. | 2011-12-20 | Traditional | PDF ↗ |
| K100780 | VITAL SUTURES, SUTUREX, CIRUGIA PERUANA | Unilene Sac | 2010-12-14 | Traditional | PDF ↗ |
| K100461 | PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT | Riverpoint Medical | 2010-07-08 | Abbreviated | PDF ↗ |
| K082097 | DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE | Demetech Corp. | 2010-01-08 | Traditional | PDF ↗ |
| K081001 | PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE | Sutures India Pvt., Ltd. | 2008-06-09 | Traditional | PDF ↗ |
| K073614 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | 2008-04-30 | Traditional | PDF ↗ |
| K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) | Surgical Specialties Corp | 2008-04-23 | Special | PDF ↗ |
| K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 | Depuy Mitek | 2008-04-23 | Special | PDF ↗ |
| K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE | Surgical Specialties Corp | 2008-03-21 | Special | PDF ↗ |
| K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL | Surgical Specialties Corp | 2007-08-06 | Traditional | PDF ↗ |
| K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES | Surgical Specialties Corp | 2007-05-09 | Traditional | PDF ↗ |
| K061037 | PDS PLUS ANTIBACTERIAL SUTURE | ETHICON, Inc. | 2006-07-14 | Traditional | PDF ↗ |
| K053380 | CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE | Surgical Specialties Corp | 2006-01-18 | Traditional | PDF ↗ |
| K051609 | QUILL SYNTHETIC ABSORBABLE BARBED SUTURE | Quill Medical, Inc. | 2005-08-04 | Traditional | PDF ↗ |
| K042285 | UNICRYL M | United Medical Industries Co. , Ltd. | 2004-12-10 | Traditional | PDF ↗ |
| K043298 | BLUE ORTHOCORD SUTURE | Depuy Mitek | 2004-12-10 | Special | PDF ↗ |
| K042075 | QUILL SYNTHETIC ABSORBABLE BARBED SUTURE | Quill Medical, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K041048 | POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE | Internacional Farmaceutica, S.A. DE C.V. | 2004-06-04 | Traditional | PDF ↗ |
| K040004 | ORTHOCORD SUTURE | Depuy Mitek | 2004-04-13 | Traditional | PDF ↗ |
| K031216 | MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE | Aesculap | 2003-07-17 | Traditional | PDF ↗ |
| K031443 | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS | Lsi Solutions | 2003-06-18 | Abbreviated | PDF ↗ |
| K030786 | MONO-SWIFT | Cp Medical | 2003-05-06 | Abbreviated | PDF ↗ |
| K030212 | MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE | Genzyme Biosurgery | 2003-03-27 | Traditional | PDF ↗ |
| K022666 | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. | Arc Medical Supplies (Beijing) Co, Ltd. | 2002-10-09 | Traditional | PDF ↗ |
| K013274 | MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE | Cp Medical | 2001-11-16 | Traditional | PDF ↗ |
Product code NEW · Class II · General, Plastic Surgery. Data: openFDA.