Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposabl…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Aveta Opal Disposable Hysteroscope EUDAMEDAveta Opal Disposable Hysteroscope, 4.6mm FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Aveta Opal Disposable Hysteroscope EUDAMEDAveta Opal Disposable Hysteroscope, 4.6mm for use with Aveta System FDA UDI
- Model / Reference
- 220-2002 EUDAMEDFDA UDI
- Description
- Aveta Opal Disposable Hysteroscope, 4.6mm for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 220-2002 FDA UDI
- Primary DI / UDI-DI
- 00850006759569 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759569EA EUDAMED
- FDA Product Code
- HIH FDA 510(k)FDA UDIHIG FDA UDI
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)FDA UDI884.1700 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Aveta System comprises disposable hysteroscope and cystoscope devices designed for diagnostic and therapeutic procedures in the female reproductive tract. These instruments fall under the category of Hysteroscope (And Accessories) and are intended for visual inspection of the uterus and bladder, respectively, using optical technology with minimal invasiveness.
The Aveta System is supplied as single-use, sterile devices, intended for use in outpatient or clinical settings by trained healthcare professionals. Each model—hysteroscope (Pearl/Opal/Coral) and cystoscope (Coral)—is regulated under FDA 510K and MDR, with a classification of Class II. Devices are packaged individually for immediate clinical use and must be stored according to manufacturer instructions to maintain sterility.
Frequently asked questions
What types of procedures is the Aveta System designed for, and how does it differ between the hysteroscope and cystoscope models?
The Aveta System includes disposable hysteroscope models (Pearl, Opal, Coral) and a disposable cystoscope (Coral) for minimally invasive visual inspection. The hysteroscope models are specifically designed for examining the uterus, while the cystoscope model is intended for inspecting the bladder. Both use optical technology and are classified under the same regulatory category (Hysteroscope and Accessories) but target different anatomical regions.
Are the Aveta disposable scopes single-use only, and how should they be stored to maintain sterility?
Yes, the Aveta System devices are single-use only and come pre-packaged as sterile instruments. To preserve sterility, they must be stored according to the manufacturer’s instructions, typically in their original sealed packaging away from moisture, extreme temperatures, and direct sunlight until immediate clinical use.
What regulatory pathways have the Aveta System and its models undergone, and which medical specialty is it primarily associated with?
The Aveta System, including its hysteroscope (Pearl/Opal/Coral) and cystoscope (Coral) models, has been authorized through FDA 510K clearance and MDR compliance. The devices fall under the Obstetrics/Gynecology medical specialty, as indicated by their advisory committee classification (OB) and product-code category (HIH).
How do I know which Aveta model is appropriate for my procedure, and are there different sizes or configurations?
The Aveta System offers three hysteroscope models (Pearl, Opal, Coral) and one cystoscope model (Coral). While the data does not specify exact sizes or configurations, the models are differentiated by their intended use (uterine vs. bladder inspection) and likely vary in design to accommodate different clinical needs. Consult the manufacturer’s documentation or a medical specialist to select the appropriate model for your procedure.
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 | K213171 | Class II | Active |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
Sources (3)
- FDA 510(k) K213171 24 fields · synced Oct 6, 2026
- FDA UDI ba3c91ae-2446-43f7-b493-eb63384cd370 35 fields · synced May 30, 2026
- EUDAMED ef9f43f6-429c-4cb3-bf1d-0fb72c71b0b4 61 fields · synced Jul 11, 2026