K232752 is an FDA 510(k) clearance for the Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C). This device is classified as a Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (Class II - Special Controls, product code GCA).
Submitted by Jiangsu Vedkang Medical Science and Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on February 26, 2024, 171 days after receiving the submission on September 8, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K232752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2023 |
| Decision Date | February 26, 2024 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCA - Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |