Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

All-Suture Dual Anchor System

K-Number: K250095 · 2025-09-05

ApplicantSuturetech, Inc.
Decision Date2025-09-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

All-Suture Dual Anchor System is a medical device manufactured by Suturetech, Inc.. It received FDA 510(k) clearance on 2025-09-05 under approval number K250095. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the All-Suture Dual Anchor System?

All-Suture Dual Anchor System is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Suturetech, Inc.. The 510(k) number is K250095.

When was All-Suture Dual Anchor System approved by the FDA?

All-Suture Dual Anchor System received FDA 510(k) clearance on 2025-09-05, under approval number K250095.

What company makes All-Suture Dual Anchor System?

All-Suture Dual Anchor System is manufactured by Suturetech, Inc..

What is the FDA product code for All-Suture Dual Anchor System?

The FDA product code for All-Suture Dual Anchor System is MBI.

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 NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07587593 The IVCare Adaptive Platform Trial 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

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.

↑