# K962116: Galileo Endoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Galileo Electro-Optics Corp.
- Decided: Nov 27, 1996 after 180 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Imagyn Laparoscope: named in the summary without a submission number
- (no number) Optimed Rigid Fiber Optic Endoscope: named in the summary without a submission number
- (no number) Fiber Optic Laparoscope: named in the summary without a submission number
- (no number) Model 2010 Rigid Fiber Optic Sinuscope: named in the summary without a submission number
- (no number) Model 4200 Fiber Optic Laparoscope: named in the summary without a submission number
- (no number) Fiber Optic Choledoscope: named in the summary without a submission number
- (no number) Rigid Sinuscope: named in the summary without a submission number
- (no number) Hopkins Laparoscopes: named in the summary without a submission number
- (no number) Thoracoscope: named in the summary without a submission number

## Most influential descendants
- K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler (1999), 2 descendants of its own
- K974297: Galileo Disposable Hysteroscopes (1998), 1 descendant of its own
- K080780: Anchorage Scope, Model 000003 (2008), 0 descendants of its own
- K993445: Omnisonic Endoscopic Deflector (1999), 0 descendants of its own
- K981828: Galileo Disposable Hysteroscopes (1998), 0 descendants of its own

## Indications for use
The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes 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. The Galileo Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.

Source page: https://510kreport.com/device/K962116
Methodology: https://510kreport.com/methodology