RenaNav Ureteroscope System— 510(k) K223097

Substantially Equivalent

CenterPoint Systems, LLC

FDA 510(k) clearance K223097 for RenaNav Ureteroscope System, Substantially Equivalent on 2023-07-31. Applicant: CenterPoint Systems, LLC.

Clearance details

Applicant: CenterPoint Systems, LLC
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-30
Decision date: 2023-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.