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FDA 510(k)

Suture-TOOL System

K-Number: K250977 · 2025-04-28

ApplicantSuturion AB
Decision Date2025-04-28
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Suture-TOOL System is the device name listed in this FDA 510(k) record. The listed applicant is Suturion AB. It received FDA 510(k) clearance on 2025-04-28 under 510(k) number K250977. 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 2025-04-28. The listed applicant is Suturion AB. The 510(k) number is K250977.

When did Suture-TOOL System receive FDA 510(k) clearance?

Suture-TOOL System received FDA 510(k) clearance on 2025-04-28, under 510(k) number K250977.

Who is the listed applicant for Suture-TOOL System?

The FDA 510(k) record lists Suturion AB as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07766044A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy ClosureRECRUITING

Other records listing Suturion AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242835Suture-TOOL System

Related Devices (Code: NEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.

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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