Clearance Summary
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S received FDA 510(k) clearance under submission number K050521, 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 2005-05-02.
- Submission: K050521
- Applicant / Sponsor: Inntec, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2005-05-02
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.