GLASS LOSS OF RESISTANCE SYRINGE— 510(k) K063018

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K063018 for GLASS LOSS OF RESISTANCE SYRINGE, Substantially Equivalent on 2007-01-22. Applicant: Busse Hospital Disposables, Inc..

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 2006-10-02
Decision date: 2007-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.