# K223040: Endo SmartCap

- Pathway: 510(k) (Special)
- Applicant: Medivators, Inc.
- Decided: Mar 1, 2023 after 153 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 K790071 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093665: Endo Smartcap, Byrne Medical, Inc. (2009) Summary page 5.

## Indications for use
The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Source page: https://510kreport.com/device/K223040
Methodology: https://510kreport.com/methodology