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FDA 510(k)

HyperSuture Extension Line

K-Number: K234079 · 2024-05-10

ApplicantThreadstone, LLC
Decision Date2024-05-10
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HyperSuture Extension Line is the device name listed in this FDA 510(k) record. The listed applicant is Threadstone, LLC. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K234079. 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 Extension Line?

HyperSuture Extension Line is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Threadstone, LLC. The 510(k) number is K234079.

When did HyperSuture Extension Line receive FDA 510(k) clearance?

HyperSuture Extension Line received FDA 510(k) clearance on 2024-05-10, under 510(k) number K234079.

Who is the listed applicant for HyperSuture Extension Line?

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

What is the FDA product code for HyperSuture Extension Line?

The FDA product code for HyperSuture Extension Line is GAT.

Other records listing Threadstone, 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.

K254275HyperSuture All Green Extension LineK242201HyperSuture White/Green Extension LineK241376HyperSuture All Blue Extension LineK230311HyperSuture

Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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