FORTUNE SILICONE VACUUM SUCTION, MODEL #1300— 510(k) K021193

Substantially Equivalent

Fortune Medical Instrument Corp.

FDA 510(k) clearance K021193 for FORTUNE SILICONE VACUUM SUCTION, MODEL #1300, Substantially Equivalent on 2003-02-12. Applicant: Fortune Medical Instrument Corp..

Clearance details

Applicant: Fortune Medical Instrument Corp.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 2002-04-15
Decision date: 2003-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Hsien, TW

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Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

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.