# K170862: Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope

- Pathway: 510(k) (Traditional)
- Applicant: Solace Therapeutics, Inc.
- Decided: Dec 19, 2017 after 271 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: 5 generations back to K770378 (1977). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories, Schoelly Fiberoptic GmbH (2015) Summary page 4.

## Indications for use
Vesair Cystoscopes are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. Vesair Cystoscopes are intended to be used in general urological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Source page: https://510kreport.com/device/K170862
Methodology: https://510kreport.com/methodology