# K132384: U-Scope 8000 System with HSC+Emb Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Endosec Corporation
- Decided: Jul 2, 2014 after 336 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: 10 generations back to K931154 (1993). 33 ancestors in all.
19 later devices descend from it; 5 cite it directly.
1 of 53 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123151: Endosee Model 8000 U-Scope, Endosee Corp (2013) Summary page 1.
- K840383: Menstrual Aspiration Kit, Intl. Medical Technologies, Inc. (1984) Summary page 1.

## Most influential descendants
- 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
- K232003: Endoscopic Video Image Processor, Single-Use Video Hysteroscope (2024), 3 descendants of its own

## Indications for use
The U-Scope 8000 HSC+EMB Cannula is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometnial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amnenorrhea, and pelvic pain.

Source page: https://510kreport.com/device/K132384
Methodology: https://510kreport.com/methodology