Clearance Summary
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, received FDA 510(k) clearance under submission number K131435, sponsored by Ethicon Endo-Surgery, LLC. 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 2013-10-03.
- Submission: K131435
- Applicant / Sponsor: Ethicon Endo-Surgery, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2013-10-03
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.