Clearance Summary
Jimushi Sterile Urethral Catheter for single use received FDA 510(k) clearance under submission number K200134, sponsored by Hangzhou Jimushi Meditech Co., Ltd.. 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 2020-06-01.
- Submission: K200134
- Applicant / Sponsor: Hangzhou Jimushi Meditech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2020-06-01
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.