Cleared Traditional

K232245 - VedDilator ^TM (3-Stage Balloon Dilatio...

K232245 is an FDA 510(k) clearance for VedDilator ^TM (3-Stage Balloon Dilatio..., manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K232245 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Gastroenterology & Urology device
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Feb 2024
Decision
202d
Days
Class 2
Risk

K232245 is an FDA 510(k) clearance for the VedDilator ^TM (3-Stage Balloon Dilation Catheter). Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Jiangsu Vedkang Medical Science and Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on February 15, 2024 after a review of 202 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 - K232245

510(k) Number K232245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date February 15, 2024
Days to Decision 202 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
72d slower than avg
Panel avg: 130d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
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 - FGE Stents, Drains And Dilators For The Biliary Ducts

All 317
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K232245.
WallFlex Biliary PLUS RX Stent System
K242950 · Boston Scientific · Dec 2024
WallFlex Biliary RX Stent System
K240464 · Boston Scientific · Aug 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
K233079 · Cook Ireland, Ltd. · Jun 2024
EndoGI S-Path Biliary Stent System
K232596 · Endogi Medical, Ltd. · Sep 2023
EGIS Biliary Single Bare Stent
K223354 · S&G Biotech, Inc. · Sep 2023
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
K230127 · Micro-Tech (Nanjing) Co., Ltd. · Sep 2023