IMPACT MODEL 323 ASPIRATOR— 510(k) K133196

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K133196 for IMPACT MODEL 323 ASPIRATOR, Substantially Equivalent on 2014-03-10. Applicant: Impact Instrumentation, Inc..

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2013-10-17
Decision date: 2014-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.