# K970937: Mist Micro Interchangeable Scope System (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Mist, Inc.
- Decided: Sep 26, 1997 after 197 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
Longest line of descent: 1 generation back to K962116 (1996). 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)
- K962116: Galileo Endoscopes, Galileo Electro-Optics Corp. (1996) Summary page 2.

## Indications for use
The MIST Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.

Source page: https://510kreport.com/device/K970937
Methodology: https://510kreport.com/methodology