Identifiers
- 510(k) Number
- K132423 FDA 510(k)
- FDA Product Code
- HEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1630 FDA 510(k)
- Regulation Number
- 884.1630 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Video colposcope - Gynocular™ - Gynius Plus - hand-held, GYNIUS PLUS AB : Quotes, Address, Contact - News-Medical.net, PDF The Gynocular - Executive marketing 2.0 Gynius AB, THE GYNOCULAR by GYNIUS AB | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132423 | Class II | Active |
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Manufacturer
- Manufacturer
- Gynius AB
Sources (1)
- FDA 510(k) K132423 24 fields · synced Sep 25, 2026