EGNELL UNIVERSAL SUCTION PUMP— 510(k) K853909

Substantially Equivalent for Some Indications

Egnell, Inc.

FDA 510(k) clearance K853909 for EGNELL UNIVERSAL SUCTION PUMP, Substantially Equivalent for Some Indications on 1985-11-25. Applicant: Egnell, Inc..

Clearance details

Applicant: Egnell, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1985-09-20
Decision date: 1985-11-25
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.