# K252012: SPY Cystoscope/Hysteroscope

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Jul 18, 2025 after 21 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
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)
- K233635: SPY Cystoscope/Hysteroscope, Stryker Endoscopy (2024) Summary page 5.
- K040390: Stryker Urology and Gynecology Hardware System, Stryker Endoscopy (2004) Summary page 5.

## Indications for use
The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Source page: https://510kreport.com/device/K252012
Methodology: https://510kreport.com/methodology