# K002838: Gastric Suction and Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bioenterics Corp.
- Decided: Jul 9, 2001 after 300 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
No predicates in its family tree.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K110529: Endoflip Gastric Tube (2011), 16 descendants of its own
- K130483: Boehringer Gastric Sizing Tube (2013), 15 descendants of its own
- K220455: Lap-Band System Calibration Tube (2022), 4 descendants of its own
- K191885: Standard Bougie (2020), 3 descendants of its own
- K221898: Gastrointestinal Boundary Identifier (GIBI HD) (2022), 2 descendants of its own

Source page: https://510kreport.com/device/K002838
Methodology: https://510kreport.com/methodology