510(k) K252012— SPY Cystoscope/Hysteroscope

Substantially Equivalent

Stryker Endoscopy

Clearance details

Applicant: Stryker Endoscopy
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2025-06-27
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.