Cleared Traditional

K834401 - URETERAL DOUBLE PIGTAIL STENT

K834401 is an FDA 510(k) clearance for URETERAL DOUBLE PIGTAIL STENT, manufactured by Hobbs Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAD cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K834401 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Mar 1984
Decision
99d
Days
Class 2
Risk

K834401 is an FDA 510(k) clearance for the URETERAL DOUBLE PIGTAIL STENT. Classified as Stent, Ureteral (product code FAD), 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 99 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - 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 - K834401

510(k) Number K834401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date March 22, 1984
Days to Decision 99 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
32d faster than avg
Panel avg: 131d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAD Device Classification - Class 2, Special Controls

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
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 - FAD Stent, Ureteral

All 104
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K834401.
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S
K850175 · Mentor Corp. · Mar 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · Mentor Corp. · Feb 1985
SURGITEK ALL SILICONE INFECTION DOUBJ
K833782 · Surgitek · Apr 1984
SILITEK URINARY DIVERSION STENT
K840059 · Surgitek · Feb 1984
URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN
K832915 · Surgitek · Oct 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
K831857 · Medical Engineering Corp. · Aug 1983