Cleared Traditional

K944614 - MEGA-BRUSH

K944614 is the FDA 510(k) clearance for MEGA-BRUSH by Biosearch Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDX) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K944614 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
197d
Days
Class 2
Risk

K944614 is an FDA 510(k) clearance for the MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 197 days - an extended review 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: 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 Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K944614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1994
Decision Date April 05, 1995
Days to Decision 197 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 130d · This submission: 197d
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 K944614.
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · Wilson-Cook Medical, Inc. · May 2004
CELL RECOVERY SYSTEM
K965037 · Medical Device Technologies, Inc. · Jan 1997
CELL RECOVERY SYSTEM
K960004 · Medical Device Technologies, Inc. · Mar 1996
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