Clearance Summary
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201 received FDA 510(k) clearance under submission number K000950, sponsored by Labotect Labor-Technik Gottingen. 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 2000-05-12.
- Submission: K000950
- Applicant / Sponsor: Labotect Labor-Technik Gottingen
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2000-05-12
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.