Clearance Summary
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) received FDA 510(k) clearance under submission number K040699, sponsored by Megadyne Medical Products, 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 2004-06-04.
- Submission: K040699
- Applicant / Sponsor: Megadyne Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2004-06-04
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.