Cleared Special

EndoGI S-Path Biliary Stent System (K232596) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232596 · Endogi Medical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
33d
Days
Class 2
Risk

K232596 is an FDA 510(k) clearance for the EndoGI S-Path 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 September 27, 2023 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Endogi Medical, Ltd. devices

Submission Details

510(k) Number K232596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 25, 2023
Decision Date September 27, 2023
Days to Decision 33 days
Submission Type Special
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
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 K232596.
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
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
K232245 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Feb 2024
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
WallFlex™ Biliary RX Stent System
K223469 · Boston Scientific Corporation · Jun 2023