BODAI SUCTION -SAFE 4— 510(k) K811241

Substantially Equivalent

Sontek Industries, Inc.

FDA 510(k) clearance K811241 for BODAI SUCTION -SAFE 4, Substantially Equivalent on 1981-05-27. Applicant: Sontek Industries, Inc..

Clearance details

Applicant: Sontek Industries, Inc.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1981-05-04
Decision date: 1981-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.