# K061306: CO-1000 Colposcope, Multiple

- Pathway: 510(k) (Traditional)
- Applicant: Gynex Corp.
- Decided: Aug 7, 2006 after 89 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940094 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021854: DFV CPG Colposcope, D.F. Vasconcellos S.A. (2002) Summary page 1.

## Indications for use
The Gynex brand Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix.

Source page: https://510kreport.com/device/K061306
Methodology: https://510kreport.com/methodology