# K181545: Hysteroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: May 10, 2019 after 332 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: 12 generations back to K931154 (1993). 35 ancestors in all.
2 later devices descend 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)
- K171113: LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module, Lina Medical Aps (2018) Summary page 4.

## Most influential descendants
- K210270: Medical Endoscope Image Processing System (2021), 1 descendant of its own
- K252793: ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) (2025), 0 descendants of its own

## Indications for use
The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: • Abnormal bleeding • Infertility and pregnancy wastage • Evaluation of abnormal hysterosalpingogram • Intrauterine foreign body • Amenorrhea • Pelvic pain Generally recognized indications for operative hysteroscopy include: • Directed endometrial biopsy • Polypectomy • Submucous myomectomy • Transection of intrauterine adhesions • Transection of intrauterine septa • Endometrial ablation

Source page: https://510kreport.com/device/K181545
Methodology: https://510kreport.com/methodology