Clearance Summary
MINNOW PENILE IMPLANT PROTECTOR received FDA 510(k) clearance under submission number K904262, sponsored by Ruja-Med Medical Marketing. 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 1990-12-13.
- Submission: K904262
- Applicant / Sponsor: Ruja-Med Medical Marketing
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.3630
- Decision date: 1990-12-13
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.