# K070845: Sounmed Coloposcope Colpo-99/99PLUS

- Pathway: 510(k) (Traditional)
- Applicant: Sounmed, Inc.
- Decided: Oct 12, 2007 after 199 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.
1 later device descends from it; 1 cites it directly.
0 of 17 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.

## Most influential descendants
- K160341: Colposcope System (2016), 0 descendants of its own

## Indications for use
The Sounmed Colposcope COLPO-99 is intended to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy.

Source page: https://510kreport.com/device/K070845
Methodology: https://510kreport.com/methodology