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.
Clearance details
- Applicant
- Teleflex Medical, LLC
- Product code
- Code GAT
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Adverse 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.