# K972119: Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX)

- Pathway: 510(k) (Traditional)
- Applicant: Medovations, Inc.
- Decided: Feb 2, 1998 after 242 days
- Product code: FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133439: Pilling Esophageal Bougies (2014), 0 descendants of its own

## Indications for use
The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.

Source page: https://510kreport.com/device/K972119
Methodology: https://510kreport.com/methodology