Cleared Traditional

K232752 - Stone Extraction Balloon (VDK-BAL-23-11...

K232752 is an FDA 510(k) clearance for Stone Extraction Balloon (VDK-BAL-23-11..., manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code GCA cleared through the Traditional 510(k) pathway after a 171-day FDA review.

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

FDA 510(k) Submission Details - K232752

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.

GCA Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (GCA) and FDA review panel - the closest regulatory comparables to K232752.
Disposable Stone Retrieval Balloon Catheter
K253013 · Zhejiang Soudon Medical Technology Co., Ltd. · May 2026
SpyGlass Discover Balloon Dilation Catheter
K212582 · Boston Scientific Corporation · May 2022
Stone Retrieval Balloon Catheter
K210660 · Anrei Medical (Hangzhou) Co., Ltd. · Apr 2021
Stone Retrieval Balloon
K200173 · Hangzhou AGS MedTech Co., Ltd. · May 2020
Fusion Quattro Extraction Balloon
K200247 · Wilson-Cook Medical, Inc. · Feb 2020
Tri-Ex Extraction Balloon with Multiple Sizing
K193344 · Wilson-Cook Medical, Inc. · Dec 2019