# K170323: Entuit Start Initial Placement Gastrostomy Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 14, 2017 after 225 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K852363 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080253: Kimberly-Clark Introducer Kits, Kimberly-Clark Corp. (2008) Summary page 4.

## Indications for use
The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

Source page: https://510kreport.com/device/K170323
Methodology: https://510kreport.com/methodology