Clearance Summary
CLAMP-N-CUT received FDA 510(k) clearance under submission number K860445, sponsored by Mmi, 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 1986-04-04.
- Submission: K860445
- Applicant / Sponsor: Mmi, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1986-04-04
Classification & Regulation
This clearance is catalogued under FDA product code HFW and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.