Clearance Summary
Lubricating Jelly received FDA 510(k) clearance under submission number K142473, sponsored by Sion Biotext Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-04-13.
- Submission: K142473
- Applicant / Sponsor: Sion Biotext Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 2015-04-13
Classification & Regulation
This clearance is catalogued under FDA product code KMJ and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.