HYDROCHECK MICRO FILTER— 510(k) K970488

Substantially Equivalent

White River Concepts

FDA 510(k) clearance K970488 for HYDROCHECK MICRO FILTER, Substantially Equivalent on 1997-11-04. Applicant: White River Concepts.

Clearance details

Applicant: White River Concepts
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 1997-02-10
Decision date: 1997-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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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.