# K851955: Savary-Gilliard Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jul 25, 1985 after 83 days
- Product code: KNQ (Dilator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031147: Optical DVS (Dual Vector Shearing) Esophageal Dilator (2004), 2 descendants of its own
- K093236: Ethicon Endo-Surgeryoptical Dilator (2009), 0 descendants of its own
- K082995: Smart Dilator (2009), 0 descendants of its own

## Recalls of this device
- Jan 5, 2006 · Not classified · Z-0441-06: The dilator size does not match the label on the product and product packaging.

Source page: https://510kreport.com/device/K851955
Methodology: https://510kreport.com/methodology
