Cleared Traditional

K834401 - URETERAL DOUBLE PIGTAIL STENT

K834401 is the FDA 510(k) clearance for URETERAL DOUBLE PIGTAIL STENT by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K834401.
MENTOR UNIVERSAL URETERAL STENT SET
K851870 · Mentor Corp. · Jul 1985
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S
K850175 · Mentor Corp. · Mar 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · Mentor Corp. · Feb 1985
BARD URETERAL STENT
K823487 · C.R. Bard, Inc. · May 1983
URETERAL STANT SET
K820870 · Van-Tec, Inc. · Apr 1982