# K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jul 13, 2017 after 132 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). 48 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 54 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories, Schoelly Fiberoptic GmbH (2015) Summary page 4.
- K123151: Endosee Model 8000 U-Scope, Endosee Corp (2013) Summary page 4.
- K132384: U-Scope 8000 System with HSC+Emb Cannula, Endosec Corporation (2014) Summary page 4.

## Most influential descendants
- K183020: Endosee System (2019), 4 descendants of its own
- K190639: Endosee System (2019), 3 descendants of its own
- K200038: Endosee System (2020), 1 descendant of its own
- K254251: InnovexView (GC146-17, GC150-20, GC155-23) (2026), 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 Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult 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 * Pelvic Pain The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic procedures.

Source page: https://510kreport.com/device/K170660
Methodology: https://510kreport.com/methodology