# K260271: Strauss Surgical cystoscope, hysteroscope and accessories Instruments

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Endoscopy, Inc.
- Decided: Mar 27, 2026 after 58 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: 2 generations back to K040390 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Henke-Sass, Wolf GmbH (2017) Summary page 5.

## Indications for use
Endoscopes: 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 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. Urology Instruments: The 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/K260271
Methodology: https://510kreport.com/methodology