Clearance Summary
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT received FDA 510(k) clearance under submission number K102274, sponsored by Arvik Enterprises/ Mini Lap Technologies. 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 2011-06-15.
- Submission: K102274
- Applicant / Sponsor: Arvik Enterprises/ Mini Lap Technologies
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2011-06-15
Classification & Regulation
This clearance is catalogued under FDA product code GAA and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.