MEADOX(R) SURGIMED(R) BIOPSY GUN II— 510(k) K911635

Substantially Equivalent

Meadox Surgimed, Inc.

FDA 510(k) clearance K911635 for MEADOX(R) SURGIMED(R) BIOPSY GUN II, Substantially Equivalent on 1991-06-20. Applicant: Meadox Surgimed, Inc..

Clearance details

Applicant: Meadox Surgimed, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-11
Decision date: 1991-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, 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.