# K260649: OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: May 21, 2026 after 83 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: 3 generations back to K895857 (1990). 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)
- K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660, Richard Wolf Medical Instruments Corp. (2001) Summary page 7.

## Indications for use
The cystoscopes and accessories are intended for endoscopic diagnosis and therapy in the lower urinary tract. Together with compatible instruments endoscopic diagnostic and therapeutic procedures can be performed. Access is gained through a minimally invasive approach by utilizing natural orifices. The product is intended to be used for patients from 18 years of age and up.

Source page: https://510kreport.com/device/K260649
Methodology: https://510kreport.com/methodology