# K971586: Digene Cervical Brush

- Pathway: 510(k) (Traditional)
- Applicant: Digene Corp.
- Decided: Sep 19, 1997 after 141 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
Longest line of descent: 1 generation back to K832986 (1984). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832986: Pap Smear Brush, Donald G. Zeller (1984) Summary page 2.

## Most influential descendants
- K993614: Fas Endoluminal Brush (2000), 3 descendants of its own
- K050889: Fibrin Analysis System Endoluminal Brush (2005), 1 descendant of its own
- K013258: Inpath E2 Collector (2002), 1 descendant of its own
- K012641: Fas Endoluminal Brush (2001), 1 descendant of its own
- K072381: Softpap Cervical Cell Collector (2008), 0 descendants of its own

## Indications for use
The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.

Source page: https://510kreport.com/device/K971586
Methodology: https://510kreport.com/methodology