NEW — Suture, Surgical, Absorbable, Polydioxanone Class II
FDA Device Classification
Classification Details
- Product Code
- NEW
- Device Class
- Class II
- Regulation Number
- 878.4840
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243897 | ethicon | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su | November 12, 2025 |
| K251414 | feeltech co | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | October 20, 2025 |
| K250107 | feeltech co | V-soft Line Barbed Surgical Suture (Various) | October 15, 2025 |
| K252644 | m/s. meril endo surgery private limited | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PIN | September 23, 2025 |
| K250977 | suturion | Suture-TOOL System | April 28, 2025 |
| K242835 | suturion | Suture-TOOL System | January 22, 2025 |
| K242571 | hyundae meditech co | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 | September 27, 2024 |
| K232246 | m/s. meril endo surgery private limited | 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; | April 25, 2024 |
| K240389 | hyundae meditech co | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread | March 27, 2024 |
| K220549 | hans biomed corporation | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift M | March 7, 2023 |
| K212380 | ethicon | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu | February 22, 2022 |
| K210871 | pdo max | PDO Max Suture with Dual Needle | December 17, 2021 |
| K201139 | foosin medical supplies inc | WEGO-PDO Barbed Suture | October 20, 2020 |
| K192423 | hans biomed corporation | MINT Product Family | September 9, 2020 |
| K192144 | ethicon | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | March 25, 2020 |
| K191361 | demetech corporation | DemeDIOX Barbed Absorbable Surgical Suture | November 7, 2019 |
| K190264 | meditime co | Viola | August 15, 2019 |
| K190245 | pdo max | PDS Barbed Suture, PDO MAXX Threads | June 4, 2019 |
| K182873 | ethicon | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral P | January 10, 2019 |
| K172602 | feeltech co | Miracu | November 14, 2018 |