# K233635: SPY Cystoscope/Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Feb 12, 2024 after 91 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: 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
- K252012: SPY Cystoscope/Hysteroscope (2025), 0 descendants of its own

## 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/K233635
Methodology: https://510kreport.com/methodology