# K200038: Endosee System

- Pathway: 510(k) (Special)
- Applicant: CooperSurgical, Inc.
- Decided: Feb 5, 2020 after 28 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: 14 generations back to K931154 (1993). 51 ancestors in all.
1 later device descends from it; 1 cites 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)
- K190639: Endosee System, CooperSurgical, Inc. (2019) Summary page 4.

## Most influential descendants
- K254251: InnovexView (GC146-17, GC150-20, GC155-23) (2026), 0 descendants of its own

## 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/K200038
Methodology: https://510kreport.com/methodology