# K993689: Aed Cystoscope

- Pathway: 510(k) (Traditional)
- Applicant: National Advanced Endoscopy Devices, Inc.
- Decided: Dec 15, 1999 after 44 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
This device is used to provide visual information about the condition of the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure. The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in: « Diagnostic cystoscopy procedures.

Source page: https://510kreport.com/device/K993689
Methodology: https://510kreport.com/methodology