Cleared Traditional

K953827 - GIP/MEDI-GLOBE ERCP CATHETERS

K953827 is an FDA 510(k) clearance for GIP/MEDI-GLOBE ERCP CATHETERS, manufactured by Medi-Globe Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K953827 · Medi-Globe Corp. · Gastroenterology & Urology device
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Sep 1995
Decision
17d
Days
Class 2
Risk

K953827 is an FDA 510(k) clearance for the GIP/MEDI-GLOBE ERCP CATHETERS. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medi-Globe Corp. (Tempe, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 17 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 Medi-Globe Corp. devices

FDA 510(k) Submission Details - K953827

510(k) Number K953827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date September 01, 1995
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
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 K953827.
MANAN BILIARY DRAINAGE CATHETER
K954043 · Manan Medical Products, Inc. · Mar 1996
ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
K955413 · Endovations · Feb 1996
MS CLASSIQUE BALLOON DILATATION CAHTETER
K953332 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1995
OLYMPUS NBD TUBES
K944912 · Olympus America, Inc. · Jun 1995
OLYMPUS PBD STENTS
K933200 · Olympus Corp. · Apr 1995
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
K941350 · Wilson-Cook Medical, Inc. · Mar 1995