Cleared Traditional

K043369 - CERVEX-BRUSH COMBI

K043369 is an FDA 510(k) clearance for CERVEX-BRUSH COMBI, manufactured by Rovers Medical Devices B.V.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K043369 · Rovers Medical Devices B.V. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
56d
Days
Class 2
Risk

K043369 is an FDA 510(k) clearance for the CERVEX-BRUSH COMBI. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Rovers Medical Devices B.V. (Oss, NL). The FDA issued a Cleared decision on February 2, 2005 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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.

FDA 510(k) Submission Details - K043369

510(k) Number K043369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date February 02, 2005
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 161d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHT Spatula, Cervical, Cytological

All 71
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K043369.
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · Bio Nuclear Diagnostics, Inc. · Dec 2008
SOFTPAP CERVICAL CELL COLLECTOR
K072381 · Cytocore, Inc. · Jan 2008
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433 · Diamics, Inc. · Mar 2007
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
K042527 · Medical Action Industries, Inc. · Nov 2004
DRG SOFTRELEASE
K041018 · Doctor'S Research Group, Inc. · Oct 2004
INPATH E2 COLLECTOR
K013258 · Molecular Diagnostics · May 2002
K043369 · CERVEX-BRUSH COMBI
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