Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
K-Number: K260775 · 2026-05-06
ApplicantTeleflex Medical, LLC
Decision Date2026-05-06
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape is a medical device manufactured by Teleflex Medical, LLC. It received FDA 510(k) clearance on 2026-05-06 under approval number K260775. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape?
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape is a medical device that received FDA 510(k) clearance on 2026-05-06. It is manufactured by Teleflex Medical, LLC. The 510(k) number is K260775.
When was Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape approved by the FDA?
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape received FDA 510(k) clearance on 2026-05-06, under approval number K260775.
What company makes Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape?
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape is manufactured by Teleflex Medical, LLC.
What is the FDA product code for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape?
The FDA product code for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape is GAT.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.