510(k) K171969
K171969 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on March 28, 2018. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2018
- Date Received
- June 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type