pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent— 510(k) K163068

Substantially Equivalent

Q Urological Corporation

FDA 510(k) clearance K163068 for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent, Substantially Equivalent on 2016-12-22. Applicant: Q Urological Corporation.

Clearance details

Applicant: Q Urological Corporation
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2016-11-02
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, 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.