Clearance Summary
REJOYN PENILE SUPPORT SYSTEM received FDA 510(k) clearance under submission number K971576, sponsored by American Medtech. 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 1997-10-16.
- Submission: K971576
- Applicant / Sponsor: American Medtech
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1997-10-16
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.