# 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

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Jan 4, 2018 after 265 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.
4 later devices descend from it; 2 cite it directly.
1 of 39 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 5.
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4, Gyrus Acmi, Inc. (2009) Summary page 5.

## Most influential descendants
- K181545: Hysteroscope System (2019), 2 descendants of its own
- 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
- K193007: LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module (2020), 0 descendants of its own

## 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 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, transection of intrauterine adhesions and septa.

Source page: https://510kreport.com/device/K171113
Methodology: https://510kreport.com/methodology