# K981928: Galileo Disposable Endoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Galileo Electro-Optics Corp.
- Decided: Aug 6, 1998 after 65 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite 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)
- 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) 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) Hopkins 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
- K192300: EnlightenVue Microendoscopy System (2020), 0 descendants of its own
- K080780: Anchorage Scope, Model 000003 (2008), 0 descendants of its own
- K993445: Omnisonic Endoscopic Deflector (1999), 0 descendants of its own
- K982630: Medworks Visualization Insemination Catheter (1999), 0 descendants of its own

## Indications for use
The Galileo Disposable Endoscopes are endoscopes intended for visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The indications include choledoscopy, cystoscopy, ureteroscopy, bronchoscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.

Source page: https://510kreport.com/device/K981928
Methodology: https://510kreport.com/methodology