TRACHESTOMY & NASAL SUCTIONING KIT #-— 510(k) K830711

Substantially Equivalent

Intertex Medical

FDA 510(k) clearance K830711 for TRACHESTOMY & NASAL SUCTIONING KIT #-, Substantially Equivalent on 1983-05-02. Applicant: Intertex Medical.

Clearance details

Applicant: Intertex Medical
Product code: Code GBZ
Advisory panel: General, Plastic Surgery
Date received: 1983-03-07
Decision date: 1983-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GBZ

product code GBZ

Death: 2
Total: 2

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.