Clearance Summary
PolyCatch Retrieval Device received FDA 510(k) clearance under submission number K142258, sponsored by Medi-Globe Corporation. 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 2014-09-30.
- Submission: K142258
- Applicant / Sponsor: Medi-Globe Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2014-09-30
Classification & Regulation
This clearance is catalogued under FDA product code FDI and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.