InnovexView - GC146-17
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K254251 FDA 510(k)
- FDA Product Code
- HIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The InnovexView (GC146-17, GC150-20, GC155-23) is a Hysteroscope (and Accessories), a diagnostic and therapeutic device used for visual inspection of the uterine cavity. It enables clinicians to examine the endometrial lining, detect abnormalities such as polyps, fibroids, or structural anomalies, and perform targeted interventions like biopsies or minor procedures under direct visualization.
This device is supplied as a reusable medical instrument, intended for use in obstetrics and gynecology settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorization. The device is designed for single-user procedures and must be sterilized between uses, adhering to standard medical device reprocessing protocols. No specific MRI safety information is provided, and the device is available in three model variants (GC146-17, GC150-20, GC155-23) for different clinical applications.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K254251 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- FDA Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K254251 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026