Clearance Summary
PHTIP DISPOSABLE ISFET CATHETER received FDA 510(k) clearance under submission number K102801, sponsored by E-Cath 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 2010-10-26.
- Submission: K102801
- Applicant / Sponsor: E-Cath Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2010-10-26
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.