Clearance Summary
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS received FDA 510(k) clearance under submission number K040295, sponsored by Applied Medical Resources Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2004-03-12.
- Submission: K040295
- Applicant / Sponsor: Applied Medical Resources Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2004-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.