Clearance Summary
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket received FDA 510(k) clearance under submission number K171969, sponsored by Wilson-Cook Medical, 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 2018-03-28.
- Submission: K171969
- Applicant / Sponsor: Wilson-Cook Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2018-03-28
Classification & Regulation
This clearance is catalogued under FDA product code LQR and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.