# K240978: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)

- Pathway: 510(k) (Traditional)
- Applicant: MacroLux Medical Technology Co., Ltd.
- Decided: Aug 16, 2024 after 128 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931154 (1993). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232003: Endoscopic Video Image Processor, Single-Use Video Hysteroscope, Guangzhou Red Pine Medical Instrument Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K254294: Single-use Digital Hysteroscope (GYUT-A 12.6- 0,  GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30,  GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22,  GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12,  GYUT-B 15-22, GYUT-B 15- 30) (2026), 0 descendants of its own

## Indications for use
The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.

Source page: https://510kreport.com/device/K240978
Methodology: https://510kreport.com/methodology