# K191885: Standard Bougie

- Pathway: 510(k) (Traditional)
- Applicant: Standard Bariatrics
- Decided: Apr 8, 2020 after 268 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: 3 generations back to K002838 (2001). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K130483: Boehringer Gastric Sizing Tube, Boehringer Laboratories, LLC (2013) Summary page 4.

## Most influential descendants
- K210437: Standard Bougie, 38 Fr. (2021), 2 descendants of its own
- 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 BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Source page: https://510kreport.com/device/K191885
Methodology: https://510kreport.com/methodology