Clearance Summary
EcoVue Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance under submission number K181363, sponsored by H R Pharmaceuticals, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-06-13.
- Submission: K181363
- Applicant / Sponsor: H R Pharmaceuticals, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2018-06-13
Classification & Regulation
This clearance is catalogued under FDA product code MUI and 21 CFR 892.1570, within the Radiology review panel as a Class II device.