Clearance Summary
IUI CATHETER, MODEL 9057 received FDA 510(k) clearance under submission number K052059, sponsored by Inntec, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2005-11-22.
- Submission: K052059
- Applicant / Sponsor: Inntec, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2005-11-22
Classification & Regulation
This clearance is catalogued under FDA product code MQF and 21 CFR 884.6110, within the Obstetrics/Gynecology review panel as a Class II device.