# K132423: The Gynocular

- Pathway: 510(k) (Traditional)
- Applicant: Gynius AB
- Decided: Apr 8, 2014 after 246 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 1.
- K031639: Intermed Zoom Colposcope, Intermed Group, Inc. (2003). Our reading of the summary gave K031629, FDA’s number for Canon Non-Mydriatic Retinal Camera, Model CR-Dgi (Canon USA, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “The Intermed Zoom Colposcope”.
- K880195: Gynescope, Medgyn Products, Inc. (1988) Summary page 1.
- K853389: Wallach Zoom Colposcope, Wallach Surgical Devices, Inc. (1985) Summary page 1.

## Indications for use
The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.

Source page: https://510kreport.com/device/K132423
Methodology: https://510kreport.com/methodology