# K183020: Endosee System

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Jan 31, 2019 after 91 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: 12 generations back to K931154 (1993). 49 ancestors in all.
4 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)
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula, CooperSurgical, Inc. (2017) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Apr 9, 2020 · Class II · Z-2112-2020: The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

## 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 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 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 procedures.

Source page: https://510kreport.com/device/K183020
Methodology: https://510kreport.com/methodology