# K190639: Endosee System

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: May 15, 2019 after 63 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931154 (1993). 50 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K183020: Endosee System, CooperSurgical, Inc. (2019) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Dec 13, 2019 · Class II · Z-0798-2020: Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).

## Indications for use
The Endosee System is used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures. The types of procedures where the Endosee System could offer visualization include: Abnormal bleeding Infertility and pregnancy wastage Evaluation of abnormal hysterosalpingogram Intrauterine foreign body Amenorrhea Pelvic pain Directed biopsy Removal of fibroids and polyps Transection of intrauterine adhesions Transection of intrauterine septa The Endosee System 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 and therapeutic procedures.

Source page: https://510kreport.com/device/K190639
Methodology: https://510kreport.com/methodology