Cleared Traditional

K233079 - Zimmon Pancreatic Stents/Stent sets (SPSOF

Also marketed or referenced as:
Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS) Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS) Pushing Catheter and Guiding Catheter (GC, PC) Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)

K233079 is the FDA 510(k) clearance for Zimmon Pancreatic Stents/Stent sets (SPSOF by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K233079 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
262d
Days
Class 2
Risk

K233079 is an FDA 510(k) clearance for the Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS). Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on June 14, 2024 after a review of 262 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 Cook Ireland, Ltd. devices

Submission Details

510(k) Number K233079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date June 14, 2024
Days to Decision 262 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
132d slower than avg
Panel avg: 130d · This submission: 262d
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 K233079.
Tornus ES
K241801 · Asahi Intecc Co., Ltd. · Dec 2024
WallFlex Biliary PLUS RX Stent System
K242950 · Boston Scientific · Dec 2024
WallFlex Biliary RX Stent System
K240464 · Boston Scientific · Aug 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
EGIS Biliary Single Bare Stent
K223354 · S&G Biotech, Inc. · Sep 2023