FDA 510(k)

HyperSuture

K-Number: K230311 · 2023-11-24

Decision Date2023-11-24

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HyperSuture is a medical device manufactured by Threadstone, LLC. It received FDA 510(k) clearance on 2023-11-24 under approval number K230311. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperSuture?

HyperSuture is a medical device that received FDA 510(k) clearance on 2023-11-24. It is manufactured by Threadstone, LLC. The 510(k) number is K230311.

When was HyperSuture approved by the FDA?

HyperSuture received FDA 510(k) clearance on 2023-11-24, under approval number K230311.

What company makes HyperSuture?

HyperSuture is manufactured by Threadstone, LLC.

What is the FDA product code for HyperSuture?

The FDA product code for HyperSuture is GAT.

Other Devices by Threadstone, LLC

K241376HyperSuture All Blue Extension Line K234079HyperSuture Extension Line K242201HyperSuture White/Green Extension Line K254275HyperSuture All Green Extension Line

Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.