K260775
- 510(k) number
- K260775
- Device name
- Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
- Applicant
- Teleflex Medical, LLC NC · US
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2026-05-06
- Date received
- 2026-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260775.pdf
Official FDA record: K260775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.