Cleared Traditional

K834402 - GASTROINTESTINAL SHEATH BRUSH

K834402 is the FDA 510(k) clearance for GASTROINTESTINAL SHEATH BRUSH by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDX) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K834402 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Feb 1984
Decision
52d
Days
Class 2
Risk

K834402 is an FDA 510(k) clearance for the GASTROINTESTINAL SHEATH BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Hobbs Medical, Inc. devices

Submission Details

510(k) Number K834402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date February 04, 1984
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDX Endoscopic Cytology Brush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Collect Cells For Cytological Evaluation.
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 - FDX Endoscopic Cytology Brush

All 25
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K834402.
GASTROINTESTINAL CYTOLOGY BRUSH
K860997 · Endovations · May 1986
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · E-Z-Em, Inc. · Oct 1985
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561 · C.R. Bard, Inc. · Jan 1985
ENDOSCOPIC CYTOLOGY BRUSHES
K791668 · Mill-Rose Laboratory · Oct 1979
UROLOGICAL BIOPSY BRUSH SET
K770913 · Cook, Inc. · Jun 1977