BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM— 510(k) K061788

Substantially Equivalent

Boehringer Laboratories

FDA 510(k) clearance K061788 for BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM, Substantially Equivalent on 2006-07-11. Applicant: Boehringer Laboratories.

Clearance details

Applicant: Boehringer Laboratories
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2006-06-26
Decision date: 2006-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norristown, PA, US

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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.