Clearance Summary
ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM received FDA 510(k) clearance under submission number K020082, sponsored by Endocare, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2002-02-05.
- Submission: K020082
- Applicant / Sponsor: Endocare, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 2002-02-05
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.