Clearance Summary
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM received FDA 510(k) clearance under submission number K921791, sponsored by Wallach Surgical Devices, Inc.. 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 1995-05-04.
- Submission: K921791
- Applicant / Sponsor: Wallach Surgical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1995-05-04
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.