# K083788: Endo Optiks Urological Catheter for Endoscopy, Model Sessr

- Pathway: 510(k) (Traditional)
- Applicant: Endooptiks, Inc.
- Decided: Mar 3, 2009 after 74 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K022135 (2002). 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)
- K022135: Ureteral Access Sheath Set (Uass), Boston Scientific Corp (2002) Summary page 1.
- K032521: Bard Dual Lumen Ureteral Catheter, C.R. Bard, Inc. (2003) Summary page 1.

## Indications for use
The Stonebuster Endoscopic System for Stone Removal (SESSR) Catheter for Endoscopy is intended to provide access to the ureteral canal and to be used to guide the currently available visualization devices and accessory devices such as biopsy forceps, cytology brushes, stone retrieval baskets, etc. during endoscopic procedures. The indications for use of the catheter are in urological applications.

Source page: https://510kreport.com/device/K083788
Methodology: https://510kreport.com/methodology