Cleared Traditional

K913986 - CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY...

K913986 is an FDA 510(k) clearance for CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY..., manufactured by Medical Dynamics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K913986 · Medical Dynamics, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 1992
Decision
145d
Days
Class 2
Risk

K913986 is an FDA 510(k) clearance for the CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 145 days - within the typical 510(k) review window.

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 Medical Dynamics, Inc. devices

FDA 510(k) Submission Details - K913986

510(k) Number K913986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 05, 1991
Decision Date January 28, 1992
Days to Decision 145 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 130d · This submission: 145d
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 K913986.
GIANTURCO-ROSCH BILIARY Z STENT
K921191 · Cook, Inc. · May 1992
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