Clearance Summary
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS received FDA 510(k) clearance under submission number K082006, sponsored by American Medical 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 2008-10-20.
- Submission: K082006
- Applicant / Sponsor: American Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.3630
- Decision date: 2008-10-20
Classification & Regulation
This clearance is catalogued under FDA product code FAE and 21 CFR 876.3630, within the Gastroenterology, Urology review panel as a Class II device.