# K962256: Galileo Hysteroscopes and Laparoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Galileo Electro-Optics Corp.
- Decided: Dec 6, 1996 after 177 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). 3 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935277: Karl Storz Hopkins (KSH) I Rigid Telescope, KSH II Rigid Telescope, KSH Rigid Operating Scopes Karl Storz Oval Sheath, KARL STORZ Endoscopy-America, Inc. (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.

## Cited in the summary but kept off the family tree
- K088270: Karl Storz Hysteroscopes and Laparoscopes. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K031974: Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 (2003), 20 descendants of its own
- K060899: Flexilux II Cystoscope and Hysteroscope (2007), 19 descendants of its own
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), 18 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own

## Indications for use
The Galileo Hysteroscopes are rigid endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Galileo Laparoscopes are intended for direct visualization of the organs within the peritoneum for diagnostic and surgical procedures on the female genital organs. The Galileo Laparoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.

Source page: https://510kreport.com/device/K962256
Methodology: https://510kreport.com/methodology