Clearance Summary
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 received FDA 510(k) clearance under submission number K990475, sponsored by Kps & Assoc., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-11-18.
- Submission: K990475
- Applicant / Sponsor: Kps & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1999-11-18
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.