Clearance Summary
Actreen Hi-Lite Intermittent Urinary Catheters received FDA 510(k) clearance under submission number K192577, sponsored by B.Braun Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-05-07.
- Submission: K192577
- Applicant / Sponsor: B.Braun Medical, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2020-05-07
Classification & Regulation
This clearance is catalogued under FDA product code GBM and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.