Cleared Traditional

K834351 - BILIARY INDWELLING STENT

K834351 is an FDA 510(k) clearance for BILIARY INDWELLING STENT, manufactured by Hobbs Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K834351 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Mar 1984
Decision
100d
Days
Class 2
Risk

K834351 is an FDA 510(k) clearance for the BILIARY INDWELLING STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984 after a review of 100 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 Hobbs Medical, Inc. devices

FDA 510(k) Submission Details - K834351

510(k) Number K834351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date March 22, 1984
Days to Decision 100 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
31d faster than avg
Panel avg: 131d · This submission: 100d
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 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K834351.
DILATION BALLOON CATHETER
K834413 · Hobbs Medical, Inc. · May 1984
DRAINAGE STENT
K834468 · Microvasive · Apr 1984
USCI ENDOPROSTHESIS
K834574 · C.R. Bard, Inc. · Apr 1984
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
K833937 · Universal Medical Instrument Corp. · Jan 1984
COONS SOFT STENT
K830483 · Medi-Tech, Inc. · Mar 1983
PIGTAIL STENTS
K821819 · American Endoscopy, Inc. · Aug 1982