Cleared Traditional

K860997 - GASTROINTESTINAL CYTOLOGY BRUSH

K860997 is an FDA 510(k) clearance for GASTROINTESTINAL CYTOLOGY BRUSH, manufactured by Endovations. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K860997 · Endovations · Gastroenterology & Urology device
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May 1986
Decision
45d
Days
Class 2
Risk

K860997 is an FDA 510(k) clearance for the GASTROINTESTINAL CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 45 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 Endovations devices

FDA 510(k) Submission Details - K860997

510(k) Number K860997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date May 02, 1986
Days to Decision 45 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
86d faster than avg
Panel avg: 131d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDX Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K860997.
WILTEK CYTOLOGY BRUSH
K894863 · Wiltek Medical, Inc. · Dec 1989
HOBBS MEDICAL MICROBIOLOGY BRUSH
K893729 · Hobbs Medical, Inc. · Aug 1989
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · Van-Tec, Inc. · Mar 1988
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH
K853530 · E-Z-Em, Inc. · Oct 1985
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561 · C.R. Bard, Inc. · Jan 1985
GASTROINTESTINAL SHEATH BRUSH
K834402 · Hobbs Medical, Inc. · Feb 1984