# K222085: Standard Tapered Bougie, 38 Fr.

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics, Inc.
- Decided: Oct 31, 2022 after 108 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 Tapered Bougie, 38Fr (STB38) 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/K222085
Methodology: https://510kreport.com/methodology