# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Geyi Medical Instrument Co., Ltd.
- Decided: Sep 8, 2026 after 251 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: 14 generations back to K931154 (1993). 37 ancestors in all.
No later device cites it as a predicate yet.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240978: SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G), MacroLux Medical Technology Co., Ltd. (2024) Summary page 5.

## Indications for use
This Single-use Digital Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. It can only be used with Geyi Medical endoscope camera system GY-AIO-121.

Source page: https://510kreport.com/device/K254294
Methodology: https://510kreport.com/methodology