Suture-TOOL System
FDA 510(k) K250977 · Suturion AB
510(k) numberK250977
Submission
- Device name
- Suture-TOOL System
- Applicant
- Suturion AB
Lund, SE - Received
- March 31, 2025
- Decision date
- April 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEW – Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4840
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253879 | Monofix PdoNEW · Traditional | Samyang Holdings Corporation | 08/25/2026SE |
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | Teleflex Medical, LLC | 07/09/2026SE |
| K252171 | Barbed PDO SutureNEW · Traditional | Sutura Medical Technology, Inc. | 06/12/2026SE |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional | ETHICON, Inc. | 05/18/2026SE |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional | ETHICON, Inc. | 11/12/2025SE |
| K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO)NEW · Traditional | Feeltech Co., Ltd. | 10/20/2025SE |
| K250107 | V-soft Line Barbed Surgical Suture (Various)NEW · Traditional | Feeltech Co., Ltd. | 10/15/2025SE |
| K252644 | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special | M/s. Meril Endo Surgery Private Limited. | 09/23/2025SE |
| K242835 | Suture-TOOL SystemNEW · Traditional | Suturion AB | 01/22/2025SE |
| K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…NEW · Special | Hyundae Meditech Co., Ltd. | 09/27/2024SE |
More from Hyundae Meditech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242835 | Suture-TOOL SystemNEW · Traditional | 01/22/2025SE |
Questions and answers
When was Suture-TOOL System cleared by the FDA?
Suture-TOOL System (K250977) received a 510(k) decision of Substantially Equivalent on April 28, 2025, 28 days after the submission was received.
What is the product code of K250977?
The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.