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FDA 510(k)

Suture-TOOL System

K-Number: K242835 · 2025-01-22

ApplicantSuturion AB
Decision Date2025-01-22
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Suture-TOOL System is a medical device manufactured by Suturion AB. It received FDA 510(k) clearance on 2025-01-22 under approval number K242835. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Suture-TOOL System?

Suture-TOOL System is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Suturion AB. The 510(k) number is K242835.

When was Suture-TOOL System approved by the FDA?

Suture-TOOL System received FDA 510(k) clearance on 2025-01-22, under approval number K242835.

What company makes Suture-TOOL System?

Suture-TOOL System is manufactured by Suturion AB.

What is the FDA product code for Suture-TOOL System?

The FDA product code for Suture-TOOL System is NEW.

Related Clinical Trials

NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT05903547 A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study COMPLETED

Other Devices by Suturion AB

K250977Suture-TOOL System

Related Devices (Code: NEW)

K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. K160761DW-1CDongwon Medical Co., Ltd. K150553FilblocAssut Europe K161737RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX UndyedMyco Medical K172602MiracuFeeltech Co., Ltd. K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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