# K190797: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

- Pathway: 510(k) (Traditional)
- Applicant: Reed Medical (Zhejiang) Co., Ltd.
- Decided: Nov 18, 2019 after 235 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: 11 generations back to K931154 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132384: U-Scope 8000 System with HSC+Emb Cannula, Endosec Corporation (2014) Summary page 4.

## Indications for use
The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

Source page: https://510kreport.com/device/K190797
Methodology: https://510kreport.com/methodology