Clearance Summary
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT received FDA 510(k) clearance under submission number K062444, sponsored by Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.. 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 2007-02-22.
- Submission: K062444
- Applicant / Sponsor: Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2007-02-22
Classification & Regulation
This clearance is catalogued under FDA product code EZD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.