Identifiers
- 510(k) Number
- K223813 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 Aveta System 2.0 is a high-end hysteroscope designed for obstetrics and gynecology procedures, offering advanced features and improved safety. This device is substantially equivalent to existing models and is intended for use in hospitals and clinical settings.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223813 | Class II | Active |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
Sources (1)
- FDA 510(k) K223813 24 fields · synced Jul 23, 2026