Clearance Summary
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine received FDA 510(k) clearance under submission number K213892, sponsored by Rb Health (Us), LLC. 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 2023-03-07.
- Submission: K213892
- Applicant / Sponsor: Rb Health (Us), LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2023-03-07
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.