Clearance Summary
GelPOINT Transvaginal Access Platform received FDA 510(k) clearance under submission number K143308, sponsored by Applied Medical Resources. 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 2015-10-13.
- Submission: K143308
- Applicant / Sponsor: Applied Medical Resources
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1640
- Decision date: 2015-10-13
Classification & Regulation
This clearance is catalogued under FDA product code HEW and 21 CFR 884.1640, within the Obstetrics/Gynecology review panel as a Class II device.