Clearance Summary
Rusch Intermittent Urethral Catheters received FDA 510(k) clearance under submission number K222279, sponsored by Teleflex Medical. 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 2022-08-29.
- Submission: K222279
- Applicant / Sponsor: Teleflex Medical
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2022-08-29
Classification & Regulation
This clearance is catalogued under FDA product code EZC and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.