# K190187: Gynescope System

- Pathway: 510(k) (Traditional)
- Applicant: Illumigyn, Ltd.
- Decided: May 8, 2019 after 96 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope, Medgyn Products, Inc. (2013) Summary page 4.

## Indications for use
The Gynescope™ System is intended for the examination of the tissues of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™ System is intended to select areas for biopsy, when indicated. The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System. The Gynescope™ System is intended for use in hospitals, clinics, and doctors' offices.

Source page: https://510kreport.com/device/K190187
Methodology: https://510kreport.com/methodology