Cleared Traditional

K834413 - DILATION BALLOON CATHETER

K834413 is an FDA 510(k) clearance for DILATION BALLOON CATHETER, 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 159-day FDA review.

K834413 · Hobbs Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
159d
Days
Class 2
Risk

K834413 is an FDA 510(k) clearance for the DILATION BALLOON CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Palmer, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 159 days - an extended review 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: 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 - K834413

510(k) Number K834413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1983
Decision Date May 22, 1984
Days to Decision 159 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
28d slower than avg
Panel avg: 131d · This submission: 159d
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 K834413.
OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
K851647 · Meadox Surgimed, Inc. · Jul 1985
VPDS-1 VENNES PANCREATIC DILATION SET
K851956 · Wilson-Cook Medical, Inc. · Jun 1985
BILIARY STENT PROSTHESIS
K844384 · Mentor Corp. · Feb 1985
DRAINAGE STENT
K834468 · Microvasive · Apr 1984
USCI ENDOPROSTHESIS
K834574 · C.R. Bard, Inc. · Apr 1984
BILIARY INDWELLING STENT
K834351 · Hobbs Medical, Inc. · Mar 1984