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Suture-TOOL System

by Suturion AB 2 variants

510(k) K242835

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242835↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK242835 Date22 Jan 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
NEW
Device Class
Class II
Regulation
21 CFR Part 878.4840
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Suture-TOOL System is a surgical device designed for the placement of absorbable polydioxanone sutures. It is classified as a Class II device under FDA regulations and is intended for use in general and plastic surgery procedures, facilitating precise tissue approximation and wound closure.

The system is supplied as a reusable medical instrument and is approved for use in sterile environments. It is compatible with MRI settings and includes multiple suture sizes and reference codes as listed in the regulatory filings. Authorisations include FDA 510(k) clearance under the Medical Device Regulation (MDR) and are registered under the relevant FDA product codes.

Other devices from Suturion AB

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Suture-TOOL System intended for, and why is it particularly useful in those settings?

    The Suture-TOOL System is designed for general and plastic surgery procedures, specifically to assist with precise tissue approximation and wound closure. Its utility lies in its ability to deliver absorbable polydioxanone sutures, which are ideal for procedures requiring gradual strength retention as tissues heal. The system’s precision aids in minimizing tissue trauma and improving cosmetic outcomes, making it particularly valuable in plastic surgery where aesthetics and functional integrity are critical.

  • Is the Suture-TOOL System reusable, and if so, what considerations should be taken during its use and reprocessing?

    Yes, the Suture-TOOL System is supplied as a reusable medical instrument, meaning it must be properly sterilized between uses. Since it is intended for sterile environments, adherence to strict reprocessing protocols—such as cleaning, disinfection, and sterilization—is essential to maintain its safety and functionality. The system’s compatibility with MRI settings also ensures it can be used in imaging environments without interference.

  • What suture sizes and reference codes are available with the Suture-TOOL System, and how do I determine the correct size for my procedure?

    The Suture-TOOL System supports multiple suture sizes, as indicated by the listed FEI numbers (e.g., 3003639970, 3013529787, etc.) in regulatory filings. The correct size depends on the tissue type and procedure requirements—thinner sutures (e.g., 3-0 or 4-0) are typically used for delicate tissues like facial skin, while thicker sutures (e.g., 2-0 or 0) may be better suited for thicker tissues or deeper wounds. Consulting the manufacturer’s documentation or a surgical reference guide aligned with your procedure will help ensure proper selection.

  • Can the Suture-TOOL System be used in MRI environments, and what implications does this have for my workflow?

    Yes, the Suture-TOOL System is explicitly designed to be compatible with MRI settings, meaning it can be used in operating rooms where magnetic resonance imaging is performed without causing interference or safety risks. This compatibility streamlines workflows in hybrid ORs or facilities where both surgical and diagnostic imaging procedures occur, reducing the need for instrument changes or additional precautions.

  • How do I verify the regulatory compliance of the Suture-TOOL System before purchasing or using it?

    The Suture-TOOL System holds FDA 510(k) clearance under the Medical Device Regulation (MDR) and is classified as a Class II device, indicating it has undergone rigorous review for safety and effectiveness. To verify compliance, check the listed FDA product codes (e.g., K242835) and registration numbers (e.g., 3003639970) against the FDA’s public database or the manufacturer’s documentation. Additionally, ensure the device carries the appropriate labeling reflecting its regulatory status, such as the FDA clearance number.