# K961536: Flexscope

- Pathway: 510(k) (Traditional)
- Applicant: Matrix Medica, Inc.
- Decided: Sep 18, 1996 after 149 days
- Product code: GDB (Endoscope, Fiber Optic)
- 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 K850393 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850393: Flexible Fiberoptic Endoscope, Microvasive (1985) Summary page 1.
- K871978: Codman Flexible Endoscope, Codman & Shurtleff, Inc. (1987) Summary page 1.

## Indications for use
The FlexScope is intended to be used for visualization of tissue in general surgical applications.

Source page: https://510kreport.com/device/K961536
Methodology: https://510kreport.com/methodology