Cleared Traditional

K232752 - 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) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232752 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
171d
Days
Class 2
Risk

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.... Classified as Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection (product code GCA), Class II - Special Controls.

Submitted by Jiangsu Vedkang Medical Science and Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on February 26, 2024 after a review of 171 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Jiangsu Vedkang Medical Science and Technology Co., Ltd. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

All 24
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K232752.
SpyGlass Discover Balloon Dilation Catheter
K212582 · Boston Scientific Corporation · May 2022
Stone Retrieval Balloon Catheter
K210660 · Anrei Medical (Hangzhou) Co., Ltd. · Apr 2021
Fusion Quattro Extraction Balloon
K200247 · Wilson-Cook Medical, Inc. · Feb 2020