K170898 is an FDA 510(k) clearance for the Wittich Nitinol Stone Basket. This device is classified as a Dislodger, Stone, Biliary (Class II - Special Controls, product code LQR).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 12, 2017, 260 days after receiving the submission on March 27, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K170898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2017 |
| Decision Date | December 12, 2017 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQR — Dislodger, Stone, Biliary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |