# K193007: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Jan 17, 2020 after 81 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). 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)
- 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 5.
- K190639: Endosee System, CooperSurgical, Inc. (2019) Summary page 5.

## Indications for use
The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope 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, submucosal myomectomy, polypectomy, transection of intrauterine adhesions and septa. The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K193007
Methodology: https://510kreport.com/methodology