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FDA 510(k)

EndoFix™Tissue Fixation System

K-Number: K251229 · 2025-08-20

ApplicantSoftac Medical Technologies
Decision Date2025-08-20
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoFix™Tissue Fixation System is a medical device manufactured by Softac Medical Technologies. It received FDA 510(k) clearance on 2025-08-20 under approval number K251229. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoFix™Tissue Fixation System?

EndoFix™Tissue Fixation System is a medical device that received FDA 510(k) clearance on 2025-08-20. It is manufactured by Softac Medical Technologies. The 510(k) number is K251229.

When was EndoFix™Tissue Fixation System approved by the FDA?

EndoFix™Tissue Fixation System received FDA 510(k) clearance on 2025-08-20, under approval number K251229.

What company makes EndoFix™Tissue Fixation System?

EndoFix™Tissue Fixation System is manufactured by Softac Medical Technologies.

What is the FDA product code for EndoFix™Tissue Fixation System?

The FDA product code for EndoFix™Tissue Fixation System is FGE.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07278869 Applause Study I - Append System Early Feasibility Study RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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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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