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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 the device name listed in this FDA 510(k) record. The listed applicant is Suturetech, Inc.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) 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. The listed applicant is Suturetech, Inc.. The 510(k) number is K250095.

When did All-Suture Dual Anchor System receive FDA 510(k) clearance?

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

Who is the listed applicant for All-Suture Dual Anchor System?

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

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 Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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