Clearance Summary
SOFTCUP(TM):2 received FDA 510(k) clearance under submission number K920792, sponsored by Ultrafem, 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 1993-10-05.
- Submission: K920792
- Applicant / Sponsor: Ultrafem, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5400
- Decision date: 1993-10-05
Classification & Regulation
This clearance is catalogued under FDA product code HHE and 21 CFR 884.5400, within the Obstetrics/Gynecology review panel as a Class II device.