The Gynocular
by Gynius AB
510(k) K132423
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132423 | Date8 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K132423
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HEX
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1630
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Gynocular is aynocular is a colposcope (and colpomicroscope) used in obstetrics and gynecology. It is a video colposcope designed for the detection of cervical cancer.
The device is hand-held, lightweight at 480g, and easily fits into a pocket or small bag. It is supplied as a reusable device and has received FDA 510(k) clearance under K132423 with product code HEX and regulation number 884.1630.
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