# K063700: Spyglass Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Scientific, Inc.
- Decided: Feb 8, 2007 after 57 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K884836 (1988). 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)
- K060962: Endogator Endoscopy Irrigation Pump, Model Egp-100, Byrne Medical, Inc. (2006) Summary page 1.
- K031773: Endo Gator System, Byrne Medical, Inc. (2003) Summary page 1.

## Indications for use
To provide irrigation during endoscopic surgical procedures

Source page: https://510kreport.com/device/K063700
Methodology: https://510kreport.com/methodology