# K210437: Standard Bougie, 38 Fr.

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics
- Decided: Jun 29, 2021 after 137 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: 4 generations back to K002838 (2001). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191885: Standard Bougie, Standard Bariatrics (2020) Summary page 4.

## Most influential descendants
- K222085: Standard Tapered Bougie, 38 Fr. (2022), 0 descendants of its own
- K212728: Standard Bougie, 38 Fr. and Hand Pump (2021), 0 descendants of its own

## Indications for use
The STANDARD BOUGIETM SB38 is indicated for use in conjunction with the Titan SGSTM 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/K210437
Methodology: https://510kreport.com/methodology