Clearance Summary
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device received FDA 510(k) clearance under submission number K183619, sponsored by Boston Scientific Corporation. 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 2019-04-16.
- Submission: K183619
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.3630
- Decision date: 2019-04-16
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.