Clearance Summary
SIMPLASTIC SUPRA PUBIC CATHETER received FDA 510(k) clearance under submission number K852200, sponsored by Franklin Medical USA, 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 1985-08-07.
- Submission: K852200
- Applicant / Sponsor: Franklin Medical USA, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1985-08-07
Classification & Regulation
This clearance is catalogued under FDA product code KOB and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.