FDA.report

510(k) K254275

Device
HyperSuture All Green Extension Line
Applicant
Threadstone, LLC
510(k) number
K254275
Product code
GAT
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-23
Date received
2025-12-30
Regulation
878.5000
Classification name
Suture, Nonabsorbable, Synthetic, Polyethylene
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Steven Boudouris
Address
1035 Benfield Blvd. Suite H Millersville MD US 21108 21108

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GAT

510(k)DeviceApplicantDecision date
K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC2026-05-06
K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.2026-02-19
K253145Pre-Sutured TendonRti Surgical, Inc.2025-10-22
K253024ProZip Knotless ImplantRiverpoint Medical2025-10-16
K252225PowerKnot High Strength SuturesMedacta International S.A.2025-09-12
K252201HS FiberRiverpoint Medical2025-08-13
K242201HyperSuture White/Green Extension LineThreadstone, LLC2025-03-27
K241376HyperSuture All Blue Extension LineThreadstone, LLC2024-08-09
K234079HyperSuture Extension LineThreadstone, LLC2024-05-10
K231163HS Fiber SuturesRiverpoint Medical2024-01-05
K230311HyperSutureThreadstone, LLC2023-11-24
K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd.2023-08-25
K223500SuperBall Meniscal Repair SystemArcuro Medical , Ltd.2023-08-10
K223122MENIX®; MENIX® DUOS.B.M. Sas (Science & Bio Materials)2023-08-03
K230510MyEllevateCynosure, LLC2023-07-06