Cleared Traditional

EndoGI Biliary Stent System (K193600) - FDA 510(k) Clearance

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

K193600 · Endogi Medical, Ltd. · Gastroenterology & Urology device
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Jun 2020
Decision
186d
Days
Class 2
Risk

K193600 is an FDA 510(k) clearance for the EndoGI Biliary Stent System. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Endogi Medical, Ltd. (Nazareth, IL). The FDA issued a Cleared decision on June 26, 2020 after a review of 186 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 Endogi Medical, Ltd. devices

Submission Details

510(k) Number K193600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date June 26, 2020
Days to Decision 186 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
56d slower than avg
Panel avg: 130d · This submission: 186d
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

ProMedoss, Inc.
Bosmat Friedman

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 212
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K193600.
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · Boston Scientific Corporation · Dec 2020
BIOTEQ Drainage Catheter Set (One Step Type)
K200103 · Bioteque Corporation · Oct 2020
EndoGI S-Path Biliary Stent System
K202477 · Endo GI Medical · Sep 2020
ConvertX Biliary Stent System
K181669 · Brightwater Medical · Mar 2019
HANAROSTENT FASTTM Biliary (NNN)
K183396 · M.I. Tech Co., Ltd. · Feb 2019
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980 · Cook Ireland, Ltd. · Nov 2018