K252012
- 510(k) number
- K252012
- Device name
- SPY Cystoscope/Hysteroscope
- Applicant
- Stryker Endoscopy CA · US
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2025-07-18
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252012.pdf
Official FDA record: K252012
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.