Cleared Special

EndoGI S-Path Biliary Stent System (K222627) - FDA 510(k) Clearance

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

K222627 · Endo GI Medical · Gastroenterology & Urology device
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Sep 2022
Decision
28d
Days
Class 2
Risk

K222627 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 Endo GI Medical (Nazareth, IL). The FDA issued a Cleared decision on September 28, 2022 after a review of 28 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 Endo GI Medical devices

Submission Details

510(k) Number K222627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2022
Decision Date September 28, 2022
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
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 K222627.
Niti-S Biliary Speed D Stent
K223626 · Taewoong Medical Co., Ltd. · May 2023
MultiStage Balloon Dilatation Catheter
K222663 · Dongguan TT Medical, Inc. · Mar 2023
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
K223592 · Boston Scientific Corporation · Dec 2022
Niti-S Biliary Slim M Stent
K221071 · Taewoong Medical Co., Ltd. · Jun 2022
Compass BDS Biliary Stent
K213946 · Cook Ireland, Ltd. · May 2022
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
K211021 · Micro-Tech (Nanjing) Co., Ltd. · May 2022