# K123151: Endosee Model 8000 U-Scope

- Pathway: 510(k) (Traditional)
- Applicant: Endosee Corp
- Decided: Mar 8, 2013 after 150 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: 9 generations back to K931154 (1993). 31 ancestors in all.
20 later devices descend from it; 2 cite it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961688: Microspan Hysteroscope, Imagyn Medical, Inc. (1996) Summary page 1.
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4, Gyrus Acmi, Inc. (2009) Summary page 2.

## Most influential descendants
- K132384: U-Scope 8000 System with HSC+Emb Cannula (2014), 19 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K202445: Hystero-V Hysteroscope (2021), 4 descendants of its own
- K183020: Endosee System (2019), 4 descendants of its own
- 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 (2018), 4 descendants of its own

## Indications for use
The U-Scope device is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. 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/K123151
Methodology: https://510kreport.com/methodology