# K970201: Gsi Cannula with Introducer

- Pathway: 510(k) (Traditional)
- Applicant: General Surgical Innovations
- Decided: Apr 21, 1997 after 90 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K903078 (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)
- K903078: Hasson Stabilizing Access Cannula, Marlo Surgical Technology (1990) Summary page 1.

## Indications for use
The intended use of the GSI Cannula with Introducer is the same as the predicate devices (Hasson Stable Access Cannula K903078). The intended use of the predicate device and the GSI Cannula with Introducer is to provide access for surgical and diagnostic instruments for the duration of a surgical procedure.

Source page: https://510kreport.com/device/K970201
Methodology: https://510kreport.com/methodology