Cleared Traditional

K942843 - CERVEX-BRUSH

K942843 is an FDA 510(k) clearance for CERVEX-BRUSH, manufactured by Rovers Diagnostic Devices. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K942843 · Rovers Diagnostic Devices · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 1994
Decision
175d
Days
Class 2
Risk

K942843 is an FDA 510(k) clearance for the CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Rovers Diagnostic Devices (Nyack, US). The FDA issued a Cleared decision on December 8, 1994 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rovers Diagnostic Devices devices

FDA 510(k) Submission Details - K942843

510(k) Number K942843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1994
Decision Date December 08, 1994
Days to Decision 175 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 160d · This submission: 175d
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 13
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K942843.
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC · Apr 2019
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
DETECT (TM) CYTOLOGY BRUSH
K933415 · Cook Ob/Gyn · Feb 1994
SPATULA FOR PAP SMEAR COLLECTION
K893229 · Medical Device Inspection Co., Inc. · Feb 1990
WALLACH CC/BRUSH
K896065 · Wallach Surgical Devices, Inc. · Jan 1990
KOTEX SUPER MAXI PADS
K890013 · Kimberly-Clark Corp. · Apr 1989