Identity
- Trade Name
- Aveta Coral Disposable Hysteroscope FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Aveta Coral Disposable Hysteroscope for use with Aveta System FDA UDI
- Model / Reference
- 214-057 FDA UDI
- Description
- Aveta Coral Disposable Hysteroscope for use with Aveta System FDA UDI
Identifiers
- Catalog Number
- 214-057 FDA UDI
- Primary DI / UDI-DI
- 00850006759057 FDA UDI
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIH FDA UDIHIG FDA UDI
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI884.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid video hysteroscope
Aveta Coral Disposable Hysteroscope by Meditrina, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HTx Jednorazowy Histeroskop — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
- Histeroscópio Descartável HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
Cleared under the same submission
K190372 also covers:
- Aveta Disposable Resecting Device 2.9 mm — Meditrina, Inc.
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc.
- Aveta Disposable Resecting Handset — Meditrina, Inc.
- Aveta Disposable Resecting Handset — Meditrina, Inc.
- Aveta Fluid Management Accessory — Meditrina, Inc.
- Aveta Max Disposable Resecting Device, 3.9 mm — Meditrina, Inc.
- Aveta Pearl Disposable Hysteroscope — Meditrina, Inc.
- Aveta Pearl Disposable Hysteroscope — Meditrina, Inc.
- Aveta Tissue Catch — Meditrina, Inc.
- Aveta Tissue Catch with Suction Tubing — Meditrina, Inc.
- Aveta Waste Bag with Tissue Catch — Meditrina, Inc.
- Aveta Waste Bag. 6L — Meditrina, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
Sources (2)
- FDA UDI f9edf7d2-2d48-4ed6-b463-a65462df9bf0 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026