SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000— 510(k) K051581

Substantially Equivalent

Sanarus Medical, Inc.

FDA 510(k) clearance K051581 for SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000, Substantially Equivalent on 2005-07-27. Applicant: Sanarus Medical, Inc..

Clearance details

Applicant: Sanarus Medical, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2005-06-15
Decision date: 2005-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, 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.