Clearance Summary
BOSS 2000-3 VACUUM ERECTION DEVICE received FDA 510(k) clearance under submission number K012670, sponsored by Pos-T-Vac, 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 2001-11-09.
- Submission: K012670
- Applicant / Sponsor: Pos-T-Vac, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 2001-11-09
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.