NEW — Suture, Surgical, Absorbable, Polydioxanone Class II
FDA product code NEW covers "Suture, Surgical, Absorbable, Polydioxanone", a Class II medical device regulated under 21 CFR 878.4840. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261988 | teleflex medical | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical | July 9, 2026 |
| K252171 | sutura medical technology | Barbed PDO Suture | June 12, 2026 |
| K252047 | ethicon | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices | May 18, 2026 |
| 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 |