The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for 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-lithotrips.
| Device ID | K171969 |
| 510k Number | K171969 |
| Device Name: | 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-Lithotrips |
| Classification | Dislodger, Stone, Biliary |
| Applicant | Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Ashley Howard |
| Correspondent | Ashley Howard Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2018-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002572751 | K171969 | 000 |
| 00827002572676 | K171969 | 000 |
| 00827002572683 | K171969 | 000 |
| 00827002572690 | K171969 | 000 |
| 00827002572706 | K171969 | 000 |
| 00827002572713 | K171969 | 000 |
| 00827002572720 | K171969 | 000 |
| 00827002572737 | K171969 | 000 |
| 00827002572744 | K171969 | 000 |
| 00827002572669 | K171969 | 000 |