Clearance Summary
IRIS-XP received FDA 510(k) clearance under submission number K212412, sponsored by Medicore Co., Ltd.. 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 2021-09-13.
- Submission: K212412
- Applicant / Sponsor: Medicore Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2021-09-13
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.