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FDA 510(k)

Strut Suture; No-Tie Button

K-Number: K253693 · 2026-03-11

ApplicantRiverpoint Medical, LLC
Decision Date2026-03-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Strut Suture; No-Tie Button is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K253693. 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 Strut Suture; No-Tie Button?

Strut Suture; No-Tie Button is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K253693.

When did Strut Suture; No-Tie Button receive FDA 510(k) clearance?

Strut Suture; No-Tie Button received FDA 510(k) clearance on 2026-03-11, under 510(k) number K253693.

Who is the listed applicant for Strut Suture; No-Tie Button?

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

What is the FDA product code for Strut Suture; No-Tie Button?

The FDA product code for Strut Suture; No-Tie Button is MBI.

Other records listing Riverpoint Medical, LLC 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.

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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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