K171915 is an FDA 510(k) clearance for the Nathanson Transcystic Bile Duct Stone Exploration Pack. 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 March 1, 2018, 248 days after receiving the submission on June 26, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K171915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2017 |
| Decision Date | March 01, 2018 |
| Days to Decision | 248 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 |