SeleneView Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SeleneView EUDAMEDSeleneView® FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Single-Use Digital Hysteroscope EUDAMEDSeleneView®, Single-Use Digital Hysteroscope, HO35 FDA UDISeleneView®, Single-Use Digital Hysteroscope, HO42-G FDA UDISeleneView®, Single-Use Digital Hysteroscope, HC29 FDA UDISeleneView®, Single-Use Digital Hysteroscope, HC29-G FDA UDISeleneView®, Single-Use Digital Hysteroscope, HC35-G FDA UDI
- Model / Reference
- HO35 EUDAMEDFDA UDIHO42-G EUDAMEDFDA UDIHC29 EUDAMEDFDA UDIHC29-G EUDAMEDFDA UDIHC35-G EUDAMEDFDA UDIHC29/ HC29-G/ HC35/ HC35-G/ HO35/ HO35-G/ HO42/ HO42-G EUDAMED
- Description
- SeleneView®, Single-Use Digital Hysteroscope, HO35 FDA UDISeleneView®, Single-Use Digital Hysteroscope, HO42-G FDA UDISeleneView®, Single-Use Digital Hysteroscope, HC29 FDA UDISeleneView®, Single-Use Digital Hysteroscope, HC29-G FDA UDISeleneView®, Single-Use Digital Hysteroscope, HC35-G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975339623203 EUDAMEDFDA UDI06975339623234 EUDAMEDFDA UDI06975339623166 EUDAMEDFDA UDI06975339623173 EUDAMEDFDA UDI06975339623197 EUDAMEDFDA UDI
- Basic UDI-DI
- 697533962005MS EUDAMED
- 510(k) Number
- FDA Product Code
- HIH FDA 510(k)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 UDI
- Market of Registration
- France EUDAMEDAustria 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 SeleneView Single-Use Digital Hysteroscope is a diagnostic device classified as a hysteroscope (and accessories) under the FDA’s nomenclature. It is designed for visual inspection of the uterine cavity, enabling real-time imaging of the endometrial lining and cervical canal through a flexible, single-use optical system with integrated digital imaging capabilities.
This device is intended for single-use in clinical settings such as outpatient clinics, operating rooms, or gynecological examination rooms. Supplied sterile and packaged individually, it requires no reprocessing and is compatible with MRI environments. Available in multiple sizes (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G), it is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a classification of Class II. Storage follows manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What clinical scenarios is the SeleneView® Single-Use Digital Hysteroscope primarily used for?
The SeleneView® Single-Use Digital Hysteroscope is designed for visual inspection of the uterine cavity, enabling real-time imaging of the endometrial lining and cervical canal. This makes it particularly useful for diagnosing conditions such as uterine polyps, fibroids, intrauterine adhesions, or abnormalities of the endometrial lining in outpatient clinics, operating rooms, or gynecological examination rooms.
How is the SeleneView® Single-Use Digital Hysteroscope supplied, and does it require reprocessing?
The device is supplied sterile and packaged individually, ensuring no reprocessing is needed. This single-use design eliminates the need for cleaning or sterilization between procedures, reducing the risk of cross-contamination and simplifying workflow.
Are there different sizes or models available, and how do I choose the right one?
Yes, the SeleneView® is available in multiple sizes and models: HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G. The selection typically depends on the patient’s anatomy, such as cervical canal diameter or uterine cavity size. Consult the manufacturer’s guidelines or clinical expertise to match the appropriate model to the procedure.
Can this device be used in an MRI environment, and what storage instructions should I follow?
Yes, the SeleneView® Single-Use Digital Hysteroscope is explicitly noted as compatible with MRI environments, making it suitable for facilities where magnetic resonance imaging is available. Storage must follow the manufacturer’s instructions to maintain sterility and functionality, typically involving a clean, dry environment away from direct sunlight or extreme temperatures.
What regulatory pathways does the SeleneView® Single-Use Digital Hysteroscope follow, and how does that affect its use?
The device has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), classified as Class II. This means it has been evaluated for safety and performance according to regulatory standards, ensuring its suitability for clinical use in both the U.S. and EU markets. The regulatory route confirms its adherence to quality and safety requirements but does not dictate clinical indications—those are determined by medical judgment.
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 | K240978 | Class II | Active |
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Manufacturer
- Manufacturer
- MacroLux Medical Technology Co., Ltd.
Sources (11)
- FDA 510(k) K240978 24 fields · synced Oct 6, 2026
- FDA UDI fb875c6f-e3a9-466f-8001-88796d1f5c2b 34 fields · synced May 29, 2026
- FDA UDI bc933272-930c-4f87-9172-5bd6c46c798a 34 fields · synced May 30, 2026
- FDA UDI 45e06263-bad9-4a93-9d5c-becd1846a87e 34 fields · synced May 30, 2026
- FDA UDI d961361a-0df9-4eaf-8948-865bc816c9a9 34 fields · synced May 30, 2026
- FDA UDI 44593993-5b40-4af0-93e1-0927b8fb7dd2 34 fields · synced May 30, 2026
- EUDAMED 3867882d-b575-402e-86eb-457b61b4a299 61 fields · synced Jul 9, 2026
- EUDAMED a5b30402-4ee3-4ae3-96f2-9da403fe363e 61 fields · synced Jul 18, 2026
- EUDAMED 9bda3a27-bb19-481f-9059-5ba841b313ec 61 fields · synced Jul 18, 2026
- EUDAMED 7d1f5677-2afb-4328-8137-2a7eb7cbc8db 61 fields · synced Jul 19, 2026
- EUDAMED b59aea06-32e2-4a76-89ff-9b85f1418165 61 fields · synced Jul 20, 2026