REVOLUTION FULL CORE BIOPSY— 510(k) K090611

Substantially Equivalent

Inrad

FDA 510(k) clearance K090611 for REVOLUTION FULL CORE BIOPSY, Substantially Equivalent on 2009-06-04. Applicant: Inrad.

Clearance details

Applicant: Inrad
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2009-03-06
Decision date: 2009-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kentwood, MI, 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.