Elvie Stride— 510(k) K210936

Substantially Equivalent

Chiaro Technology Limited

FDA 510(k) clearance K210936 for Elvie Stride, Substantially Equivalent on 2021-08-25. Applicant: Chiaro Technology Limited.

Clearance details

Applicant: Chiaro Technology Limited
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2021-03-29
Decision date: 2021-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.