FDA.report

510(k) K260775

Device
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™
Applicant
Teleflex Medical, LLC
510(k) number
K260775
Product code
GAT
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-06
Date received
2026-03-10
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
Laura Medlin
Address
3015 Carrington Mill Blvd. Morrisville NC US 27560 27560

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

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K253024ProZip Knotless ImplantRiverpoint Medical2025-10-16
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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