Cleared Traditional

K893729 - HOBBS MEDICAL MICROBIOLOGY BRUSH

K893729 is the FDA 510(k) clearance for HOBBS MEDICAL MICROBIOLOGY 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 103-day FDA review.

K893729 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Aug 1989
Decision
103d
Days
Class 2
Risk

K893729 is an FDA 510(k) clearance for the HOBBS MEDICAL MICROBIOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 103 days - within the typical 510(k) review window.

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: 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 K893729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date August 28, 1989
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
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 K893729.
LAPAROSCOPIC CLEANING BRUSH INSTRUMENT
K911481 · United States Endoscopy Group, Inc. · Apr 1991
BC BRUSHES
K902737 · Olympus Corp. · Aug 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · Wilson-Cook Medical, Inc. · Apr 1990
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · Van-Tec, Inc. · Mar 1988
GASTROINTESTINAL CYTOLOGY BRUSH
K860997 · Endovations · May 1986
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · E-Z-Em, Inc. · Oct 1985