About This 510(k) Submission
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), 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 review panel. Regulated under 21 CFR 876.5010.