# K033191: Sohniks

- Pathway: 510(k) (Traditional)
- Applicant: Sohniks Endoscopy, Inc.
- Decided: Mar 9, 2004 after 160 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: 1 generation back to K023783 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023783: Sohniks, Sohniks Endoscopy, Inc. (2003) Summary page 1.

## Indications for use
The intended use for S6hniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urethra, prostate, bladder, and other urologic problems. This device is used as a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K033191
Methodology: https://510kreport.com/methodology