# K173355: Gastric Sizing Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Nov 17, 2017 after 23 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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 K002838 (2001). 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)
- K030841: Cook Gastric Sizing Balloon Catheter, Cook, Inc. (2003) Summary page 4.

## Indications for use
The Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

Source page: https://510kreport.com/device/K173355
Methodology: https://510kreport.com/methodology