Clearance Summary
URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY received FDA 510(k) clearance under submission number K944972, sponsored by Myo/Kinetic Systems, 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 1995-03-08.
- Submission: K944972
- Applicant / Sponsor: Myo/Kinetic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1800
- Decision date: 1995-03-08
Classification & Regulation
This clearance is catalogued under FDA product code EXY and 21 CFR 876.1800, within the Gastroenterology, Urology review panel as a Class II device.