Cleared Traditional

K914504 - CYTOLOGY BRUSH

K914504 is an FDA 510(k) clearance for CYTOLOGY BRUSH, manufactured by Surgitek Medical Engineering Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K914504 · Surgitek Medical Engineering Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
132d
Days
Class 2
Risk

K914504 is an FDA 510(k) clearance for the CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Surgitek Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 132 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 Surgitek Medical Engineering Corp. devices

FDA 510(k) Submission Details - K914504

510(k) Number K914504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1991
Decision Date February 18, 1992
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 130d · This submission: 132d
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 26
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K914504.
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
K944614 · Biosearch Medical Products, Inc. · Apr 1995
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · Boston Scientific Corp · Sep 1993
CYTOLOGY BRUSH
K924104 · United States Endoscopy Group, Inc. · Nov 1992
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