HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM— 510(k) K781038

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K781038 for HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM, Substantially Equivalent on 1978-08-14. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1978-06-19
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.