Clearance Summary
EMBRYON TRANSFER CATHETERS/SETS received FDA 510(k) clearance under submission number K994327, sponsored by Rocket Medical Plc. 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 2000-02-28.
- Submission: K994327
- Applicant / Sponsor: Rocket Medical Plc
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2000-02-28
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.