# K151878: Video Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 1, 2015 after 145 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: 2 generations back to K940094 (1995). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K181034: Pocket Colposcope System (2018), 1 descendant of its own
- K233043: Smart Scope® CX (2024), 0 descendants of its own

## Indications for use
The C3A, C6A video colposcope is intended for gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose 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 or to touch the patient.

Source page: https://510kreport.com/device/K151878
Methodology: https://510kreport.com/methodology