# K133439: Pilling Esophageal Bougies

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 16, 2014 after 216 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
Longest line of descent: 1 generation back to K972119 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972119: Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX), Medovations, Inc. (1998) Summary page 2.

## Indications for use
The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.

Source page: https://510kreport.com/device/K133439
Methodology: https://510kreport.com/methodology