SELECTACUT BIOPSY DEVICE— 510(k) K914215

Substantially Equivalent

Biomni Medical Systems, Inc.

FDA 510(k) clearance K914215 for SELECTACUT BIOPSY DEVICE, Substantially Equivalent on 1992-02-24. Applicant: Biomni Medical Systems, Inc..

Clearance details

Applicant: Biomni Medical Systems, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1991-09-19
Decision date: 1992-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpine, UT, US

Download summary PDF View on FDA.gov ↗

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.