# K012929: Flexible Pediatric Cystoureteroscope, Model Aur- 735

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Nov 19, 2001 after 80 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use for the AUR-735 Flexible Pediatric Cystoureteroscope is to examine the urinary tract of pediatric patients, and with the use of additional accessories, perform various diagnostic and therapeutic procedures on pediatric patients.

Source page: https://510kreport.com/device/K012929
Methodology: https://510kreport.com/methodology