Cleared Abbreviated

K001119 - ROVERS ENDOCERVEX-BRUSH

K001119 is an FDA 510(k) clearance for ROVERS ENDOCERVEX-BRUSH, manufactured by Rovers Medical Devices B.V.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Abbreviated 510(k) pathway after a 42-day FDA review.

K001119 · Rovers Medical Devices B.V. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
42d
Days
Class 2
Risk

K001119 is an FDA 510(k) clearance for the ROVERS ENDOCERVEX-BRUSH. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Rovers Medical Devices B.V. (Pasadena, US). The FDA issued a Cleared decision on May 19, 2000 after a review of 42 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rovers Medical Devices B.V. devices

FDA 510(k) Submission Details - K001119

510(k) Number K001119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date May 19, 2000
Days to Decision 42 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 160d · This submission: 42d
Pathway characteristics
Standards-based clearance path.

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 27
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K001119.
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC · Apr 2019
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
ORIBRUSH - STANDARD - B002
K991593 · Orifice Medical AB · Jun 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595 · Orifice Medical AB · Jun 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · Harwill Medical (Pty) , Ltd. · Mar 1999
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599 · Andwin Scientific · Dec 1998