# K031147: Optical DVS (Dual Vector Shearing) Esophageal Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jan 12, 2004 after 277 days
- Product code: KNQ (Dilator, Esophageal)
- 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 K851955 (1985). 1 ancestor in all.
2 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)
- K851955: Savary-Gilliard Dilator, Wilson-Cook Medical, Inc. (1985) Summary page 1.

## Most influential descendants
- K093236: Ethicon Endo-Surgeryoptical Dilator (2009), 0 descendants of its own
- K082995: Smart Dilator (2009), 0 descendants of its own

## Indications for use
The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

Source page: https://510kreport.com/device/K031147
Methodology: https://510kreport.com/methodology