Clearance Summary
ERECTAID received FDA 510(k) clearance under submission number K803111, sponsored by Burditt & Calkins-Siemens-Elema. 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 1981-01-23.
- Submission: K803111
- Applicant / Sponsor: Burditt & Calkins-Siemens-Elema
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.3630
- Decision date: 1981-01-23
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.