Cleared Traditional

K885180 - EXPANDABLE BILIARY STENT ENDOPROSTHESIS

K885180 is an FDA 510(k) clearance for EXPANDABLE BILIARY STENT ENDOPROSTHESIS, manufactured by Schneider Intl., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K885180 · Schneider Intl., Ltd. · Gastroenterology & Urology device
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Feb 1989
Decision
64d
Days
Class 2
Risk

K885180 is an FDA 510(k) clearance for the EXPANDABLE BILIARY STENT ENDOPROSTHESIS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Minneapolis, US). The FDA issued a Cleared decision on February 16, 1989 after a review of 64 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 Schneider Intl., Ltd. devices

FDA 510(k) Submission Details - K885180

510(k) Number K885180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1988
Decision Date February 16, 1989
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K885180.
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
K896069 · Wilson-Cook Medical, Inc. · Dec 1989
BURNEY GALLBLADDER CATHETER KIT
K880343 · Mallinckrodt Critical Care · May 1989
COOK-GIANTURCO BILIARY Z STENT
K882610 · Cook, Inc. · Apr 1989
MODIFIED COPE SUTURE ANCHOR
K873606 · Cook, Inc. · Jun 1988
NAMIC HAWKINS UNIVERSAL DRAINAGE SET
K873954 · North American Instrument Corp. · Jan 1988
SHEATH, ENDOSCOPE
K862059 · Endovations · Nov 1986