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510(k) K943220

Device
SUTULENE
Applicant
SUTURES LTD.
510(k) number
K943220
Product code
GAT  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1994-12-05
Date received
1994-07-05
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
Third party reviewed
No

Applicant Contact#

Contact
ELEANOR JONES
Address
Vauxhall Ind. Estate Ruabon, Wrexham GB LL14 6HA LL14 6HA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC2026-05-06
K254275HyperSuture All Green Extension LineThreadstone, LLC2026-03-23
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

Legacy Summary#

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FDA Review#

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