Clearance Summary
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 received FDA 510(k) clearance under submission number K002981, sponsored by Ethicon Endo-Surgery, Inc.. 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 2001-04-09.
- Submission: K002981
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2001-04-09
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.