K240192 is an FDA 510(k) clearance for the Single-use Extraction Baskets, a Dislodger, Stone, Biliary (Class II — Special Controls, product code LQR), submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 15, 2024, 265 days after receiving the submission on January 24, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K240192 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 2024 |
| Decision Date | October 15, 2024 |
| Days to Decision | 265 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 |