EZ-SPACER— 510(k) K933090

Substantially Equivalent

Airpharma, LLC

FDA 510(k) clearance K933090 for EZ-SPACER, Substantially Equivalent on 1994-02-10. Applicant: Airpharma, LLC.

Clearance details

Applicant: Airpharma, LLC
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1993-06-24
Decision date: 1994-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramona, CA, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.