Clearance Summary
V-HEPES PLUS received FDA 510(k) clearance under submission number K213293, sponsored by Vitromed Langenfeld. 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 2022-09-14.
- Submission: K213293
- Applicant / Sponsor: Vitromed Langenfeld
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2022-09-14
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.