Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape— 510(k) K260775
Substantially EquivalentTeleflex Medical, LLC
FDA 510(k) clearance K260775 for Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape, Substantially Equivalent on 2026-05-06. Applicant: Teleflex Medical, LLC. Device class: 2.
Summary
Teleflex Medical's record covers three items: Polyethylene, Polyethylene Fusion and Polyethylene OrthoTape. The product code is GAT, nonabsorbable synthetic polyethylene sutures.
Class II, 21 CFR 878.5000. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Teleflex filed from Morrisville, North Carolina. The decision came 57 calendar days after receipt (March 10 to May 6, 2026).
Clearance details
- Device name as filed
- Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
- Applicant
- Teleflex Medical, LLC
- Product code
- Product code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code GAT
view allMore clearances from Teleflex Medical, LLC
view allAdverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.