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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical, LLC. It received FDA 510(k) clearance on 2026-05-06 under 510(k) 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. The listed applicant is Teleflex Medical, LLC. The 510(k) number is K260775.

When did Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ receive FDA 510(k) clearance?

Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ received FDA 510(k) clearance on 2026-05-06, under 510(k) number K260775.

Who is the listed applicant for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™?

The FDA 510(k) record lists Teleflex Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™?

The FDA product code for Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ is GAT.

Other records listing Teleflex Medical, LLC as applicant

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Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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