Clearance Summary
INSEMINATION CATHETER, MODEL 320301 received FDA 510(k) clearance under submission number K021438, sponsored by Labotect Labor-Technik Gottingen. 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 2002-07-16.
- Submission: K021438
- Applicant / Sponsor: Labotect Labor-Technik Gottingen
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 2002-07-16
Classification & Regulation
This clearance is catalogued under FDA product code MFD and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.