ConvertX Nephroureteral Stent System— 510(k) K161277

Substantially Equivalent

Brightwater Medical

FDA 510(k) clearance K161277 for ConvertX Nephroureteral Stent System, Substantially Equivalent on 2016-11-22. Applicant: Brightwater Medical.

Clearance details

Applicant: Brightwater Medical
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2016-05-06
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunlap, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.