# K981828: Galileo Disposable Hysteroscopes

- Pathway: 510(k) (Traditional)
- Applicant: Netoptix Corp.
- Decided: Jul 7, 1998 after 46 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: 2 generations back to K770378 (1977). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974297: Galileo Disposable Hysteroscopes, Netoptix Corp. (1998) Summary page 1.
- 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.

## Indications for use
The Galileo Disposable Hysteroscopes are endoscopes intended for visualization of the cervical canal and uterine cavity for diagnostic and surgical 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. The Hysteroscope is indicated for surgical procedures such as directed biopsy, removal of submucous fibroids and large polyps, submucous myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.

Source page: https://510kreport.com/device/K981828
Methodology: https://510kreport.com/methodology