Cleared Traditional

K222663 - MultiStage Balloon Dilatation Catheter

K222663 is the FDA 510(k) clearance for MultiStage Balloon Dilatation Catheter by Dongguan TT Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K222663 · Dongguan TT Medical, Inc. · Gastroenterology & Urology device
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Mar 2023
Decision
188d
Days
Class 2
Risk

K222663 is an FDA 510(k) clearance for the MultiStage Balloon Dilatation Catheter. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on March 9, 2023 after a review of 188 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 Dongguan TT Medical, Inc. devices

Submission Details

510(k) Number K222663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2022
Decision Date March 09, 2023
Days to Decision 188 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
58d slower than avg
Panel avg: 130d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Zi-medical, Inc.
Mingzi Hussey

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K222663.
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
WallFlex™ Biliary RX Stent System
K223469 · Boston Scientific Corporation · Jun 2023
Niti-S Biliary Speed D Stent
K223626 · Taewoong Medical Co., Ltd. · May 2023
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
K223592 · Boston Scientific Corporation · Dec 2022
EndoGI S-Path Biliary Stent System
K222627 · Endo GI Medical · Sep 2022
Niti-S Biliary Slim M Stent
K221071 · Taewoong Medical Co., Ltd. · Jun 2022