Clearance Summary
INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER received FDA 510(k) clearance under submission number K983604, sponsored by Washington Regulatory Services. 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 1999-05-27.
- Submission: K983604
- Applicant / Sponsor: Washington Regulatory Services
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 1999-05-27
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.