# K212728: Standard Bougie, 38 Fr. and Hand Pump

- Pathway: 510(k) (Special)
- Applicant: Standard Bariatrics
- Decided: Sep 23, 2021 after 27 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: 5 generations back to K002838 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210437: Standard Bougie, 38 Fr., Standard Bariatrics (2021) Summary page 4.

## Indications for use
The STANDARD BOUGIE SB38 is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

Source page: https://510kreport.com/device/K212728
Methodology: https://510kreport.com/methodology