Clearance Summary
SCC-23 SAFETY CLAMP AND CUTTER received FDA 510(k) clearance under submission number K982464, sponsored by Women First Healthcare, 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 1998-08-11.
- Submission: K982464
- Applicant / Sponsor: Women First Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1998-08-11
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.