Clearance Summary
UROGRAM CYSTOMETROGRAM received FDA 510(k) clearance under submission number K936041, 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 1994-04-18.
- Submission: K936041
- Applicant / Sponsor: Myo/Kinetic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1994-04-18
Classification & Regulation
This clearance is catalogued under FDA product code FEN and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.