← Back to catalogue

SeleneView® Single-Use Digital Hysteroscope - HO42

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240978

by MacroLux Medical Technology Co., Ltd.

Identifiers

510(k) Number
K240978 FDA 510(k)
FDA Product Code
HIH FDA 510(k)
Models / Variants
HC29 FDA 510(k)EUDAMED
HC29-G FDA 510(k)EUDAMED
HC35 FDA 510(k)EUDAMED
HC35-G FDA 510(k)EUDAMED
HO35 FDA 510(k)EUDAMED
HO35-G FDA 510(k)EUDAMED
HO42 FDA 510(k)EUDAMED
HO42-G FDA 510(k)EUDAMED

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 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

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
MacroLux Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K240978 24 fields · synced Oct 7, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026