NEW
- Product code
- NEW
- Device name
- Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4840
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 66
510(k) clearances, last 3 years (13)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253879 | 2026-08-25 | Samyang Holdings Corporation | MONOFIX PDO | |
| K261988 | 2026-07-09 | Teleflex Medical, LLC | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Sy | |
| K252171 | 2026-06-12 | Sutura Medical Technology, Inc. | Barbed PDO Suture | |
| K252047 | 2026-05-18 | ETHICON, Inc. | STRATAFIX Symmetric PDS Plus Knotless Tissue Contr | |
| K243897 | 2025-11-12 | ETHICON, Inc. | PDS Plus Antibacterial (Polydioxanone) Sterile Synt | |
| K251414 | 2025-10-20 | Feeltech Co., Ltd. | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | |
| K250107 | 2025-10-15 | Feeltech Co., Ltd. | V-soft Line Barbed Surgical Suture (Various) | |
| K252644 | 2025-09-23 | M/s. Meril Endo Surgery Private Limite | PINION PDO Knotless Suture - Absorbable Poly (P-Dio | |
| K250977 | 2025-04-28 | Suturion AB | Suture-TOOL System | |
| K242835 | 2025-01-22 | Suturion AB | Suture-TOOL System | |
| K242571 | 2024-09-27 | Hyundae Meditech Co., Ltd. | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC197 | |
| K232246 | 2024-04-25 | M/s. Meril Endo Surgery Private Limite | 1) PINION PDO Knotless Suture - Absorbable Poly (P- | |
| K240389 | 2024-03-27 | Hyundae Meditech Co., Ltd. | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E1 | FDA |
Official FDA classification page: NEW
Classification and pathway per current FDA publications. Data from openFDA (CC0).