# K071764: Realize Gastric Calibration Tube, Models GCT180, GCT360

- Pathway: 510(k) (Traditional)
- Applicant: Obtech Medical Sarl
- Decided: Oct 24, 2007 after 117 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.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COOK® Gastric Sizing Balloon Catheter: named in the summary without a submission number
- (no number) BioEnterics® Gastric Balloon Suction Catheter: named in the summary without a submission number

## Most influential descendants
- K130483: Boehringer Gastric Sizing Tube (2013), 15 descendants of its own
- K191885: Standard Bougie (2020), 3 descendants of its own
- K210437: Standard Bougie, 38 Fr. (2021), 2 descendants of its own
- K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (2024), 1 descendant of its own
- K234145: ViSiGi 3D Gastric Sizing Tube (2024), 1 descendant of its own

## Indications for use
The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

Source page: https://510kreport.com/device/K071764
Methodology: https://510kreport.com/methodology