# K971896: Galileo High Resolution Micro Coupler

- Pathway: 510(k) (Traditional)
- Applicant: Netoptix Corp.
- Decided: Oct 10, 1997 after 141 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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 K903458 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903458: Precision Optics Image Coupler, Precise Optics (1990) Summary page 1.

## Indications for use
The Galileo Micro Coupler is indicated for use with endoscopy. It is an interface which allows the transmission of optical image from the endoscope to a video camera for video recording or viewing on a monitor.

Source page: https://510kreport.com/device/K971896
Methodology: https://510kreport.com/methodology