Clearance Summary
ERECTION DEVICE received FDA 510(k) clearance under submission number K896061, sponsored by Clyde Engineering Service. 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 1990-03-07.
- Submission: K896061
- Applicant / Sponsor: Clyde Engineering Service
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1990-03-07
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.