Cleared Traditional

K903420 - SOEHENDRA STENT RETRIEVER

K903420 is an FDA 510(k) clearance for SOEHENDRA STENT RETRIEVER, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K903420 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
83d
Days
Class 2
Risk

K903420 is an FDA 510(k) clearance for the SOEHENDRA STENT RETRIEVER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 22, 1990 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K903420

510(k) Number K903420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 22, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 131d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K903420.
ERCP CANNULA
K905714 · Everest Medical Corp. · Feb 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
K905229 · Arrow Intl., Inc. · Jan 1991
ZIMMON ENDOSCOPIC PANCREATIC STENT
K900923 · Wilson-Cook Medical, Inc. · Oct 1990
COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
K903858 · Cook, Inc. · Oct 1990
PR CANNULAS
K902734 · Olympus Corp. · Aug 1990
WILSON-COOK SYRINGE HOLDERS
K902107 · Wilson-Cook Medical, Inc. · Jul 1990