Clearance Summary
GOOSEN SELF-LUBRICATING CATHETER received FDA 510(k) clearance under submission number K923848, sponsored by Goosen Enterprises, 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 1994-02-18.
- Submission: K923848
- Applicant / Sponsor: Goosen Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1994-02-18
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.