DURASIL I AND DURASIL II— 510(k) K973730

Substantially Equivalent

Hanson Medical, Inc.

FDA 510(k) clearance K973730 for DURASIL I AND DURASIL II, Substantially Equivalent on 1997-12-24. Applicant: Hanson Medical, Inc..

Clearance details

Applicant: Hanson Medical, Inc.
Product code: Code MIB
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-30
Decision date: 1997-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.