# K171336: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Henke-Sass, Wolf GmbH
- Decided: Dec 7, 2017 after 213 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 K040390 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040390: Stryker Urology and Gynecology Hardware System, Stryker Endoscopy (2004) Summary page 4.

## Most influential descendants
- K260271: Strauss Surgical cystoscope, hysteroscope and accessories Instruments (2026), 0 descendants of its own

## Indications for use
a. Endoscopes The Henke-Sass, Wolf Cystoscopes/Hysteroscopes 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 the anatomy, as the surgeon deems appropriate. The Henke-Sass, Wolf Cystoscopes/Hysteroscopes are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site. b. Urology Instruments The Henke-Sass, Wolf Urology Instruments in combination with endoscopes are intended to provide the user with the means for endoscopic visualization during examination, diagnosis and therapy of the lower urinary tract in conjunction with endoscopic accessories, or as the surgeon deems appropriate. The instruments are intended for use in urological procedures through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Source page: https://510kreport.com/device/K171336
Methodology: https://510kreport.com/methodology