# K030841: Cook Gastric Sizing Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jul 11, 2003 after 116 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: 1 generation back to K002838 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002838: Gastric Suction and Drainage Catheter, Bioenterics Corp. (2001) Summary page 2.

## Most influential descendants
- K173355: Gastric Sizing Balloon Catheter (2017), 0 descendants of its own

## Indications for use
The Cook 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/K030841
Methodology: https://510kreport.com/methodology