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FDA 510(k)

Grappler Suture Anchor R3FLEX IOL System

K-Number: K240594 · 2024-03-26

ApplicantParagon 28, Inc.
Decision Date2024-03-26
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Grappler Suture Anchor R3FLEX IOL System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-03-26 under approval number K240594. 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 Grappler Suture Anchor R3FLEX IOL System?

Grappler Suture Anchor R3FLEX IOL System is a medical device that received FDA 510(k) clearance on 2024-03-26. It is manufactured by Paragon 28, Inc.. The 510(k) number is K240594.

When was Grappler Suture Anchor R3FLEX IOL System approved by the FDA?

Grappler Suture Anchor R3FLEX IOL System received FDA 510(k) clearance on 2024-03-26, under approval number K240594.

What company makes Grappler Suture Anchor R3FLEX IOL System?

Grappler Suture Anchor R3FLEX IOL System is manufactured by Paragon 28, Inc..

What is the FDA product code for Grappler Suture Anchor R3FLEX IOL System?

The FDA product code for Grappler Suture Anchor R3FLEX IOL 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)

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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.

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