SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012— 510(k) K080171

Substantially Equivalent

Sanarus Medical, Inc.

FDA 510(k) clearance K080171 for SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012, Substantially Equivalent on 2008-03-06. Applicant: Sanarus Medical, Inc..

Clearance details

Applicant: Sanarus Medical, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2008-01-24
Decision date: 2008-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, 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.