Cleared Traditional

K853666 - ENDODYNAMICS SIEGEL THERAPUTIC STENT

K853666 is an FDA 510(k) clearance for ENDODYNAMICS SIEGEL THERAPUTIC STENT, manufactured by E-Z-Em, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K853666 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
63d
Days
Class 2
Risk

K853666 is an FDA 510(k) clearance for the ENDODYNAMICS SIEGEL THERAPUTIC STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 63 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 E-Z-Em, Inc. devices

FDA 510(k) Submission Details - K853666

510(k) Number K853666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date November 05, 1985
Days to Decision 63 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
68d faster than avg
Panel avg: 131d · This submission: 63d
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 405
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K853666.
ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY
K855142 · Angiomed U.S., Inc. · Mar 1986
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954 · Wilson-Cook Medical, Inc. · Dec 1985
ZIMMON BILIARY STENT SET
K851962 · Wilson-Cook Medical, Inc. · Dec 1985
BARD-PARKER BILIARY BALLOON CATHETER
K852293 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
DAVOL RETRIEVAL BALLOON CATHETER
K853543 · C.R. Bard, Inc. · Sep 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · Cook, Inc. · Sep 1985