Clearance Summary
IUP - TIP TRANS, IUP - PROXI TRANS received FDA 510(k) clearance under submission number K961290, sponsored by Scientific Device Manufacturer, LLC. 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 1996-10-15.
- Submission: K961290
- Applicant / Sponsor: Scientific Device Manufacturer, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 1996-10-15
Classification & Regulation
This clearance is catalogued under FDA product code KXO and 21 CFR 884.2700, within the Obstetrics/Gynecology review panel as a Class II device.