# K043369: Cervex-Brush Combi

- Pathway: 510(k) (Traditional)
- Applicant: Rovers Medical Devices B.V.
- Decided: Feb 2, 2005 after 56 days
- Product code: HHT (Spatula, Cervical, Cytological)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cervex-Brush: named in the summary without a submission number
- (no number) EndoCervex-Brush: named in the summary without a submission number

## Indications for use
The Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Cervex-Brush Combi is not intended for use in pregnant women.

Source page: https://510kreport.com/device/K043369
Methodology: https://510kreport.com/methodology