# K254251: InnovexView (GC146-17, GC150-20, GC155-23)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: Feb 26, 2026 after 59 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: 15 generations back to K931154 (1993). 52 ancestors in all.
No later device cites it as a predicate yet.
1 of 53 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200038: Endosee System, CooperSurgical, Inc. (2020) Summary page 5.

## Indications for use
The InnovexView is intended to be used for direct viewing of the cervical canal and the uterine cavity, or female urinary tract, including the bladder for the purpose of performing diagnostic and therapeutic surgical procedures. The types of procedures where the InnovexView could offer visualization include: * Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram; * Assessment of infertility and pregnancy wastage; * Confirmation of the presence of intrauterine foreign body; * Assist in locating submucosal fibroids and polyps targeted for removal; * Provide visual guidance during directed biopsy, polypectomy, submucosal myomectomy, transection of intrauterine adhesions and septa. The InnovexView can also be used to permit viewing of the female adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K254251
Methodology: https://510kreport.com/methodology