Clearance Summary
LINEBERGER EXTERNAL MALE CATHETER received FDA 510(k) clearance under submission number K800890, sponsored by Lineberger External Catheter Co.. 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 1980-06-20.
- Submission: K800890
- Applicant / Sponsor: Lineberger External Catheter Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1980-06-20
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.