Cleared Traditional

K230127 - Biliary Plastic Stent

K230127 is the FDA 510(k) clearance for Biliary Plastic Stent by Micro-Tech (Nanjing) Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K230127 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Sep 2023
Decision
232d
Days
Class 2
Risk

K230127 is an FDA 510(k) clearance for the Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Sten.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 6, 2023 after a review of 232 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 Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K230127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date September 06, 2023
Days to Decision 232 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
102d slower than avg
Panel avg: 130d · This submission: 232d
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 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 K230127.
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
K232245 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Feb 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
WallFlex™ Biliary RX Stent System
K223469 · Boston Scientific Corporation · Jun 2023
Niti-S Biliary Speed D Stent
K223626 · Taewoong Medical Co., Ltd. · May 2023
MultiStage Balloon Dilatation Catheter
K222663 · Dongguan TT Medical, Inc. · Mar 2023