# K093725: Cystoscope, Models CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C

- Pathway: 510(k) (Traditional)
- Applicant: Canada Endoscope Corporation
- Decided: Aug 30, 2010 after 270 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
Longest line of descent: 2 generations back to K963426 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031141: Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope, Asap Endoscopic Products GmbH (2003) Summary page 1.

## Indications for use
Like the predicated devices, the Canada Endloscope is used to visualize the urinary tract for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K093725
Methodology: https://510kreport.com/methodology