Clearance Summary
X-Y Lubricating Jelly received FDA 510(k) clearance under submission number K220226, sponsored by R&R Medical Corporation, 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 2023-03-28.
- Submission: K220226
- Applicant / Sponsor: R&R Medical Corporation, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2023-03-28
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.