# K160341: Colposcope System

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
- Decided: Sep 14, 2016 after 219 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: 4 generations back to K940094 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000, Goldway Us, Inc. (2003) Summary page 4.
- K070845: Sounmed Coloposcope Colpo-99/99PLUS, Sounmed, Inc. (2007) Summary page 4.
- K140754: Cooper Surgical Leisegang Colposcope System, CooperSurgical, Inc. (2014) Summary page 5.

## Indications for use
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.

Source page: https://510kreport.com/device/K160341
Methodology: https://510kreport.com/methodology