Clearance Summary
INSEMI-CATH II received FDA 510(k) clearance under submission number K954398, sponsored by Cook Urological, 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 1995-12-19.
- Submission: K954398
- Applicant / Sponsor: Cook Urological, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 1995-12-19
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.