FDA.reportPublic FDA data

510(k) K242237

Device
Jewel Soft Tissue Reinforcement Device (102-6005)
Applicant
Xiros Limited
510(k) number
K242237
Product code
QUW
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-15
Date received
2024-07-30
Regulation
878.3300
Classification name
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Grannells Janet
Address
Springfield House Whitehouse Ln. Yeadon GB LS19 7UE LS19 7UE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QUW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro2025-05-30
K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.2022-12-27