Clearance Summary
ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G) received FDA 510(k) clearance under submission number K223760, sponsored by Ethicon Endo-Surgery. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-03-15.
- Submission: K223760
- Applicant / Sponsor: Ethicon Endo-Surgery
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2023-03-15
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.