Clearance Summary
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM received FDA 510(k) clearance under submission number K964848, sponsored by Marlow Surgical Technologies, 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 1997-01-16.
- Submission: K964848
- Applicant / Sponsor: Marlow Surgical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 1997-01-16
Classification & Regulation
This clearance is catalogued under FDA product code MFD and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.