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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K260775
Device Name Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™
Applicant
Teleflex Medical, LLC
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Laura Medlin
Correspondent
Teleflex Medical, LLC
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Rebecca Walker
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/10/2026
Decision Date 05/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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