# K040390: Stryker Urology and Gynecology Hardware System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: May 17, 2004 after 90 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 7 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Devices and surgery systems marketed by Henke Sass Wolf: named in the summary without a submission number
- (no number) Devices and surgery systems marketed by Omnitech Systems: named in the summary without a submission number
- (no number) Devices and surgery systems marketed by GIMMI: named in the summary without a submission number
- (no number) Devices and surgery systems marketed by ACMI: named in the summary without a submission number

## Most influential descendants
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), 18 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K183020: Endosee System (2019), 4 descendants of its own
- K091465: Myosure Rod Lens Hysteroscope (2009), 4 descendants of its own

## Indications for use
The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra, and cold-slitting of urethral strictures Trans-urethral incision and resection of the prostate Trans-urethral removal of bladder tumors Trans-cervical resection and ablation of the endometrium Trans-cervical resection of fibroids

Source page: https://510kreport.com/device/K040390
Methodology: https://510kreport.com/methodology