Clearance Summary
PatCom Single-Use Introducer received FDA 510(k) clearance under submission number K192691, sponsored by H&A Mui 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 2020-02-21.
- Submission: K192691
- Applicant / Sponsor: H&A Mui Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2020-02-21
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.