Clearance Summary
AquaFlate Pre-Filled Sterile Water Syringe 10mL received FDA 510(k) clearance under submission number K200556, sponsored by H R Pharmaceuticals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-03-31.
- Submission: K200556
- Applicant / Sponsor: H R Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2020-03-31
Classification & Regulation
This clearance is catalogued under FDA product code EZL and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.