# K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Aug 10, 2001 after 87 days
- Product code: FBO (Cystourethroscope)
- 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 K895857 (1990). 3 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes, Richard Wolf Medical Instruments Corp. (1998) Summary page 4.
- (no number) Pre-amendment Cysto-Urethroscopes: named in the summary without a submission number

## Most influential descendants
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), 6 descendants of its own

## Indications for use
The Cysto-Urethroscopes “E-Line” and Accessories are used to visualize and manipulate bladder, urethra and ureter via natural passages. The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage. The obturator/viewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed. The inserts are used to guide and angle flexible auxiliary instruments. The attachments (adapters) serve to connect endoscope and sheath. The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages. Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.

Source page: https://510kreport.com/device/K011496
Methodology: https://510kreport.com/methodology