WHITTLESTONE EXPRESSER— 510(k) K051112

Substantially Equivalent

Whittlestone, Inc.

FDA 510(k) clearance K051112 for WHITTLESTONE EXPRESSER, Substantially Equivalent on 2005-09-07. Applicant: Whittlestone, Inc..

Clearance details

Applicant: Whittlestone, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2005-05-02
Decision date: 2005-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, 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.