HyperSuture All Blue Extension Line

FDA 510(k) K241376 · Threadstone, LLC

Substantially Equivalent

510(k) numberK241376

Submission

Device name
HyperSuture All Blue Extension Line
Applicant
Threadstone, LLC
Millersville, MD, US
Received
May 15, 2024
Decision date
August 9, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5000
Specialty
General, Plastic Surgery
Implant
Yes

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K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™GAT · Traditional Teleflex Medical, LLC05/06/2026SE
K254275HyperSuture All Green Extension LineGAT · Traditional Threadstone, LLC03/23/2026SE
K254188Meniscus VersaflexGAT · Traditional GM Dos Reis Industria e Comercio Ltda.02/19/2026SE
K253145Pre-Sutured TendonGAT · Special Rti Surgical, Inc.10/22/2025SE
K253024ProZip Knotless ImplantGAT · Special Riverpoint Medical10/16/2025SE
K252225PowerKnot High Strength SuturesGAT · Traditional Medacta International S.A.09/12/2025SE
K252201HS FiberGAT · Special Riverpoint Medical08/13/2025SE
K242201HyperSuture White/Green Extension LineGAT · Traditional Threadstone, LLC03/27/2025SE

More from Threadstone, LLC

510(k)DeviceDecision
K254275HyperSuture All Green Extension LineGAT · Traditional 03/23/2026SE
K242201HyperSuture White/Green Extension LineGAT · Traditional 03/27/2025SE
K234079HyperSuture Extension LineGAT · Traditional 05/10/2024SE
K230311HyperSutureGAT · Traditional 11/24/2023SE

Questions and answers

When was HyperSuture All Blue Extension Line cleared by the FDA?

HyperSuture All Blue Extension Line (K241376) received a 510(k) decision of Substantially Equivalent on August 9, 2024, 86 days after the submission was received.

What is the product code of K241376?

The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.