Clearance Summary
RESPONSE EXTERNAL PENILE RIGIDITY DEVICE received FDA 510(k) clearance under submission number K900559, sponsored by Smith-Collins Pharmaceutical, 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 1990-05-02.
- Submission: K900559
- Applicant / Sponsor: Smith-Collins Pharmaceutical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1990-05-02
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.