Cleared Traditional

EGIS Biliary Single Bare Stent (K223354) - FDA 510(k) Clearance

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

K223354 · S&G Biotech, Inc. · Gastroenterology & Urology device
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Sep 2023
Decision
323d
Days
Class 2
Risk

K223354 is an FDA 510(k) clearance for the EGIS Biliary Single Bare Stent. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by S&G Biotech, Inc. (Yongin-Si, KR). The FDA issued a Cleared decision on September 21, 2023 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 S&G Biotech, Inc. devices

Submission Details

510(k) Number K223354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 02, 2022
Decision Date September 21, 2023
Days to Decision 323 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
193d slower than avg
Panel avg: 130d · This submission: 323d
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 213
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K223354.
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
EndoGI S-Path Biliary Stent System
K232596 · Endogi Medical, Ltd. · 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
Niti-S Biliary Speed D Stent
K223626 · Taewoong Medical Co., Ltd. · May 2023