MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY— 510(k) K022879

Substantially Equivalent

Sanarus Medical, Inc.

FDA 510(k) clearance K022879 for MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY, Substantially Equivalent on 2002-09-23. Applicant: Sanarus Medical, Inc..

Clearance details

Applicant: Sanarus Medical, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2002-08-30
Decision date: 2002-09-23
Decision: Substantially Equivalent
Clearance type: Special
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.