SEDLACEK HANDLE— 510(k) K926179

Substantially Equivalent

Simpson/Basye, Inc.

FDA 510(k) clearance K926179 for SEDLACEK HANDLE, Substantially Equivalent on 1994-03-25. Applicant: Simpson/Basye, Inc..

Clearance details

Applicant: Simpson/Basye, Inc.
Product code: Code HGI
Advisory panel: Obstetrics/Gynecology
Date received: 1992-12-08
Decision date: 1994-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code HGI

product code HGI

Other: 1
Total: 1

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.