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Suture-TOOL System

by Suturion AB 2 variants

510(k) K250977

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Special NumberK250977 Date28 Apr 2025ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 20 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 suture device designed for tissue approximation and wound closure using absorbable polydioxanone sutures. It is classified as a Class II medical device under special controls, intended for general and plastic surgery applications. The system incorporates sutures that are bioabsorbable, gradually breaking down and being absorbed by the body over time.

The device is supplied as a sterile, single-use system and is intended for use in operating room settings. It is not MRI-safe, and sizes are specified by the included suture gauges and lengths. Authorised for use in the United States under an FDA 510(k) clearance (K250977), the system meets regulatory requirements for absorbable surgical sutures. Storage instructions and additional regulatory details are outlined in the accompanying documentation.

Other devices from Suturion AB

Questions

AI-generated answers, 20 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 surgeries is the Suture-TOOL System intended for and why does it use polydioxanone sutures?

    The Suture-TOOL System is designed for general and plastic surgery applications, specifically for tissue approximation and wound closure. It uses absorbable polydioxanone sutures because these sutures gradually break down and are absorbed by the body over time, reducing the need for suture removal and minimizing tissue reaction. This makes it ideal for procedures where long-term support isn’t required, yet secure initial closure is essential.

  • Is the Suture-TOOL System reusable or single-use, and how should it be stored?

    The Suture-TOOL System is sterile and single-use only, meaning it should not be reused after a single surgical procedure. Storage instructions are detailed in the accompanying documentation, but generally, it should be kept in a dry, clean environment away from direct sunlight or extreme temperatures to maintain sterility and functionality until use.

  • What sizes and suture configurations are available in the Suture-TOOL System, and how are they specified?

    The Suture-TOOL System is available in multiple suture gauges and lengths, which define its sizes. These specifications are listed in the product documentation, and the exact configurations (e.g., 2-0, 3-0, or 4-0 gauges paired with varying lengths) are tailored to different surgical needs. The system does not provide a fixed set of sizes but rather offers flexibility based on the included suture options.

  • Can the Suture-TOOL System be used in MRI environments, and what regulatory approval does it hold?

    The Suture-TOOL System is not MRI-safe, meaning it should not be used in MRI environments due to potential interference or safety risks. It holds FDA 510(k) clearance (K250977) for use in the United States, confirming it meets regulatory requirements for absorbable surgical sutures under Class II special controls for general and plastic surgery applications.

  • How does the absorbable nature of the sutures impact post-operative care compared to non-absorbable sutures?

    Since the Suture-TOOL System uses absorbable polydioxanone sutures, they eliminate the need for suture removal, which simplifies post-operative care. Patients avoid follow-up visits for suture extraction, and the body gradually resorbs the sutures over time, reducing the risk of infection or irritation from lingering sutures. This is particularly advantageous in plastic surgery or procedures where minimizing scarring and patient discomfort are priorities.