Clearance Summary
VTU-1 VACUUM ERECTION SYSTEM received FDA 510(k) clearance under submission number K971257, sponsored by Mckenna & Cuneo. 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 1997-10-03.
- Submission: K971257
- Applicant / Sponsor: Mckenna & Cuneo
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1997-10-03
Classification & Regulation
This clearance is catalogued under FDA product code LKY and 21 CFR 876.5020, within the Gastroenterology, Urology review panel as a Class II device.