BUSSE BAC/SHIELD— 510(k) K902297

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K902297 for BUSSE BAC/SHIELD, Substantially Equivalent on 1990-08-17. Applicant: Busse Hospital Disposables, Inc..

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1990-05-23
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.