# K062433: Diamics Cercol Cervical Sample Collector System

- Pathway: 510(k) (Traditional)
- Applicant: Diamics, Inc.
- Decided: Mar 16, 2007 after 207 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K861389: Pap Smear Kit, Intl. Cytobrush, Inc. (1986) Summary page 1.

## Indications for use
The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.

Source page: https://510kreport.com/device/K062433
Methodology: https://510kreport.com/methodology