# K093236: Ethicon Endo-Surgeryoptical Dilator

- Pathway: 510(k) (Special)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Nov 10, 2009 after 26 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: 2 generations back to K851955 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031147: Optical DVS (Dual Vector Shearing) Esophageal Dilator, Ethicon Endo-Surgery, Inc. (2004) Summary page 1.

## Indications for use
The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

Source page: https://510kreport.com/device/K093236
Methodology: https://510kreport.com/methodology