Cleared Traditional

K914277 - WALLSTENT TRANS BILIARY ENDO W/UNISTEP ...

K914277 is an FDA 510(k) clearance for WALLSTENT TRANS BILIARY ENDO W/UNISTEP ..., manufactured by Schneider U.S. Stent Div.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K914277 · Schneider U.S. Stent Div. · Gastroenterology & Urology device
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Nov 1991
Decision
66d
Days
Class 2
Risk

K914277 is an FDA 510(k) clearance for the WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Schneider U.S. Stent Div. (Plymouth, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 66 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 U.S. Stent Div. devices

FDA 510(k) Submission Details - K914277

510(k) Number K914277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1991
Decision Date November 29, 1991
Days to Decision 66 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 130d · This submission: 66d
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 K914277.
GIANTURCO-ROSCH BILIARY Z STENT
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ACKRAD ERCP CONTRAST DELIVERY SET
K915813 · Ackrad Laboratories · Mar 1992
URESIL FIXATION DEVICE
K914699 · Uresil Corp. · Feb 1992
PERCUTANEOUS DILATOR WITH SHEATH
K913932 · Interventional Therapeutics Corp. · Nov 1991
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
K913073 · Biosearch Medical Products, Inc. · Oct 1991
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
K913841 · Endovations · Oct 1991