# K974297: Galileo Disposable Hysteroscopes

- Pathway: 510(k) (Traditional)
- Applicant: Netoptix Corp.
- Decided: Feb 13, 1998 after 88 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: 1 generation back to K770378 (1977). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962116: Galileo Endoscopes, Galileo Electro-Optics Corp. (1996) Summary page 1.
- K925968: Endoscope, United States Surgical, A Division of Tyco Healthc (1994) Summary page 1.
- K880314: Hysteroscope Autonom 4992, Richard Wolf Medical Instruments Corp. (1988) Summary page 1.
- K770378: Laparoscope, Fiber Light, Palmer-Jacobs, Richard Wolf Medical Instruments Corp. (1977) Summary page 1.

## Most influential descendants
- K981828: Galileo Disposable Hysteroscopes (1998), 0 descendants of its own

## Indications for use
The Galileo Hysteroscopes are endoscopes intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Hysteroscope diagnostic indications include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain.

Source page: https://510kreport.com/device/K974297
Methodology: https://510kreport.com/methodology