Clearance Summary
PROSTATIC URETHRO. BALLOON DILATATION CATHETER received FDA 510(k) clearance under submission number K873295, sponsored by Medi-Tech, 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 1989-07-31.
- Submission: K873295
- Applicant / Sponsor: Medi-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5520
- Decision date: 1989-07-31
Classification & Regulation
This clearance is catalogued under FDA product code KOE and 21 CFR 876.5520, within the Gastroenterology, Urology review panel as a Class II device.