Clearance Summary
ENSEAL TRIO TISSUE SEALING DEVICE received FDA 510(k) clearance under submission number K123141, sponsored by Ethicon Endo-Surgery, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-10-25.
- Submission: K123141
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2012-10-25
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.